Directory · 598 entries
The latest 600 US FDA recall enforcement reports
The US Food and Drug Administration publishes a weekly Enforcement Report listing recalls once they are classified 1. Class I is the most serious, where a product may cause serious harm or death, and Class III the least 2. This table lists the 600 most recent reports in the openFDA enforcement data on 6 November 2026, 200 each for food, drugs and devices, with the recall number, recalling firm, class, status, dates and stated reason 3.
598 / 598
H-0130-2027 1
H-0158-2027 1
H-0162-2027 1
H-0141-2027 1
- Recalling firm
- El Ruisenor De Mexico, Inc. 1
- Product type
- Food 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 24 August 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- undeclared allergen ingredient (Sesame, Peanuts, Wheat, Soy, Almonds, Walnuts, Yellow#5, Yellow#6, Red#40, Blue#2) 1
H-0120-2027 1
H-0104-2027 1
H-0159-2027 1
H-0155-2027 1
H-0165-2027 1
H-0132-2027 1
H-0123-2027 1
H-0119-2027 1
H-0136-2027 1
H-0117-2027 1
H-0129-2027 1
H-0106-2027 1
H-0160-2027 1
H-0149-2027 1
H-0154-2027 1
H-0112-2027 1
H-0167-2027 1
H-0174-2027 1
H-0150-2027 1
H-0121-2027 1
H-0164-2027 1
H-0134-2027 1
H-0133-2027 1
H-0116-2027 1
H-0146-2027 1
H-0137-2027 1
H-0096-2027 1
H-0111-2027 1
H-0170-2027 1
H-0124-2027 1
H-0139-2027 1
H-0105-2027 1
H-0118-2027 1
H-0125-2027 1
H-0138-2027 1
H-0152-2027 1
H-0151-2027 1
H-0153-2027 1
H-0144-2027 1
H-0108-2027 1
H-0173-2027 1
H-0169-2027 1
H-0171-2027 1
H-0157-2027 1
H-0103-2027 1
H-0113-2027 1
H-0115-2027 1
H-0163-2027 1
H-0128-2027 1
H-0102-2027 1
H-0172-2027 1
- Recalling firm
- PRIMAL SUPPLEMENTS GROUP LLC 1
- Product type
- Food 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 27 February 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- FDA laboratory analysis confirmed that Primal Herbs Volume contains sildenafil not listed on the product label. 1
H-0145-2027 1
H-0168-2027 1
H-0109-2027 1
H-0131-2027 1
H-0156-2027 1
H-0148-2027 1
H-0122-2027 1
H-0147-2027 1
H-0140-2027 1
H-0143-2027 1
H-0161-2027 1
H-0166-2027 1
H-0110-2027 1
H-0126-2027 1
H-0114-2027 1
H-0142-2027 1
H-0127-2027 1
H-0107-2027 1
H-0135-2027 1
H-0094-2027 1
H-0090-2027 1
H-0095-2027 1
H-0091-2027 1
H-0093-2027 1
H-0089-2027 1
H-0092-2027 1
H-0015-2027 1
H-0021-2027 1
H-0026-2027 1
H-0016-2027 1
H-0003-2027 1
H-0008-2027 1
H-0027-2027 1
H-0022-2027 1
H-0007-2027 1
N/A 1
H-0014-2027 1
H-0011-2027 1
H-0013-2027 1
- Recalling firm
- Berlin Seeds 1
- Product type
- Food 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 12 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Product contains alfalfa seed recalled by the supplier due to potential E. coli and/or Salmonella contamination. 1
H-0024-2027 1
H-0017-2027 1
H-0025-2027 1
- Recalling firm
- J K Patisserie & Bakery LLC 1
- Product type
- Food 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 4 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Product contains undeclared soybean oil and soy lecithin in the Ingredient Statement. Soy was not declared in the Contains statement. 1
H-0002-2027 1
H-0023-2027 1
H-0009-2027 1
H-0020-2027 1
H-0012-2027 1
H-1407-2026 1
- Recalling firm
- TODD'S SEEDS LLC 1
- Product type
- Food 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 11 September 2026 1
- Report date
- 7 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) 1
H-1402-2026 1
H-1399-2026 1
H-1397-2026 1
H-1405-2026 1
- Recalling firm
- TODD'S SEEDS LLC 1
- Product type
- Food 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 11 September 2026 1
- Report date
- 7 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) 1
H-1403-2026 1
H-1398-2026 1
- Recalling firm
- Salata Dressings, LLC 1
- Product type
- Food 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 6 August 2026 1
- Report date
- 7 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- This recall was initiated due to potential Salmonella contamination in diced jalape¿no received from the supplier 1
H-1409-2026 1
- Recalling firm
- TODD'S SEEDS LLC 1
- Product type
- Food 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 11 September 2026 1
- Report date
- 7 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) 1
H-1408-2026 1
- Recalling firm
- TODD'S SEEDS LLC 1
- Product type
- Food 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 11 September 2026 1
- Report date
- 7 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) 1
H-0001-2027 1
H-1406-2026 1
- Recalling firm
- TODD'S SEEDS LLC 1
- Product type
- Food 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 11 September 2026 1
- Report date
- 7 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) 1
H-1400-2026 1
H-1401-2026 1
H-1404-2026 1
- Recalling firm
- TODD'S SEEDS LLC 1
- Product type
- Food 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 11 September 2026 1
- Report date
- 7 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) 1
H-1395-2026 1
H-1396-2026 1
H-1393-2026 1
H-1391-2026 1
H-1392-2026 1
H-1394-2026 1
H-1390-2026 1
H-1389-2026 1
H-1339-2026 1
H-1364-2026 1
H-1379-2026 1
H-1387-2026 1
H-1355-2026 1
H-1354-2026 1
H-1378-2026 1
H-1351-2026 1
H-1342-2026 1
H-1349-2026 1
H-1356-2026 1
H-1348-2026 1
H-1382-2026 1
- Recalling firm
- Buckhead Meat Company D.B.A. Trinity Seafood 1
- Product type
- Food 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 24 July 2026 1
- Report date
- 23 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The Firm was notified by NJ Department of Health of two samples collected from tuna with reported high levels of scombrotoxin. 1
H-1386-2026 1
H-1385-2026 1
H-1368-2026 1
H-1376-2026 1
H-1373-2026 1
H-1362-2026 1
H-1377-2026 1
H-1357-2026 1
H-1384-2026 1
H-1358-2026 1
H-1372-2026 1
H-1363-2026 1
H-1360-2026 1
H-1383-2026 1
H-1374-2026 1
H-1365-2026 1
H-1366-2026 1
H-1352-2026 1
H-1350-2026 1
H-1338-2026 1
H-1388-2026 1
- Recalling firm
- Optimus Inc. d/b/a/ Markys Caviar 1
- Product type
- Food 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 25 August 2026 1
- Report date
- 23 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The firm was notified by their Brie Cheese supplier that sample results revealed the presence of Listeria monocytogenes. 1
H-1347-2026 1
H-1346-2026 1
H-1361-2026 1
H-1340-2026 1
H-1375-2026 1
H-1359-2026 1
H-1336-2026 1
H-1344-2026 1
H-1367-2026 1
H-1345-2026 1
H-1343-2026 1
H-1380-2026 1
H-1353-2026 1
H-1337-2026 1
H-1331-2026 1
- Recalling firm
- EURO FOODS GROUP USA NJ INC 1
- Product type
- Food 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 1 August 2026 1
- Report date
- 16 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The firm imported and distributed dried ribbon fish that was not properly eviscerated prior to drying. 1
H-1335-2026 1
H-1330-2026 1
H-1341-2026 1
H-1334-2026 1
H-1305-2026 1
H-1327-2026 1
H-1320-2026 1
H-1325-2026 1
H-1329-2026 1
H-1308-2026 1
H-1304-2026 1
H-1328-2026 1
H-1326-2026 1
H-1309-2026 1
H-1307-2026 1
H-1303-2026 1
- Recalling firm
- Ron's Home Style Foods, Inc. 1
- Product type
- Food 1
- Class
- Class I 1
- Status
- Terminated 1
- Recall started
- 6 August 2026 1
- Report date
- 9 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Products were manufactured with jalapenos that have the potential to be contaminated with Salmonella 1
H-1306-2026 1
H-1323-2026 1
H-1322-2026 1
H-1319-2026 1
H-1324-2026 1
H-1302-2026 1
- Recalling firm
- Ron's Home Style Foods, Inc. 1
- Product type
- Food 1
- Class
- Class I 1
- Status
- Terminated 1
- Recall started
- 6 August 2026 1
- Report date
- 9 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Products were manufactured with jalapenos that have the potential to be contaminated with Salmonella 1
H-1321-2026 1
H-1258-2026 1
- Recalling firm
- H & U Inc. dba Sun Noodle 1
- Product type
- Food 1
- Class
- Class I 1
- Status
- Terminated 1
- Recall started
- 4 August 2026 1
- Report date
- 2 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Soba sauce packet, which contains bonito, sardine, and mackerel (fish), was packed into Sura Tanmen Hot and Sour Flavor ramen noodle package kit, but fish species are... 1
H-1259-2026 1
H-1278-2026 1
D-0062-2027 1
D-0082-2027 1
- Recalling firm
- Par Health USA, LLC 1
- Product type
- Drug 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 13 October 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution. 1
D-0060-2027 1
D-0056-2027 1
D-0067-2027 1
D-0058-2027 1
D-0066-2027 1
D-0079-2027 1
D-0054-2027 1
D-0076-2027 1
- Recalling firm
- Hikma Pharmaceuticals USA INC. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 6 October 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity. 1
D-0050-2027 1
D-0057-2027 1
D-0068-2027 1
D-0049-2027 1
D-0084-2027 1
D-0083-2027 1
- Recalling firm
- Par Health USA, LLC 1
- Product type
- Drug 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 13 October 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution. 1
D-0064-2027 1
D-0052-2027 1
D-0059-2027 1
D-0045-2027 1
D-0069-2027 1
D-0061-2027 1
D-0053-2027 1
D-0070-2027 1
D-0051-2027 1
D-0055-2027 1
D-0065-2027 1
D-0063-2027 1
D-0041-2027 1
D-0038-2027 1
D-0042-2027 1
D-0039-2027 1
D-0040-2027 1
D-0006-2027 1
D-0021-2027 1
- Recalling firm
- Carolina Infusion, LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Lack of Assurance of Sterility: Related to processing equipment used in compounded product. 1
D-0027-2027 1
- Recalling firm
- Carolina Infusion, LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Lack of Assurance of Sterility: Related to formulation using bacteriostic water, Related to processing equipment used in compounded product. 1
D-0022-2027 1
- Recalling firm
- Carolina Infusion, LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Lack of Assurance of Sterility: Related to processing equipment used in compounded product. 1
D-0023-2027 1
- Recalling firm
- Carolina Infusion, LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Lack of Assurance of Sterility: Related to processing equipment used in compounded product. 1
D-0025-2027 1
- Recalling firm
- Carolina Infusion, LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Lack of Assurance of Sterility: Related to processing equipment used in compounded product. 1
D-0004-2027 1
D-0014-2027 1
D-0032-2027 1
- Recalling firm
- Carolina Infusion, LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Lack of Assurance of Sterility: Related to formulation using bacteriostic water, Related to processing equipment used in compounded product. 1
D-0016-2027 1
D-0007-2027 1
D-0024-2027 1
- Recalling firm
- Carolina Infusion, LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Lack of Assurance of Sterility: Related to processing equipment used in compounded product. 1
D-0036-2027 1
D-0013-2027 1
D-0031-2027 1
- Recalling firm
- Carolina Infusion, LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Lack of Assurance of Sterility: Related to formulation using bacteriostic water, Related to processing equipment used in compounded product. 1
D-0034-2027 1
D-0030-2027 1
- Recalling firm
- Carolina Infusion, LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Lack of Assurance of Sterility: Related to formulation using bacteriostic water, Related to processing equipment used in compounded product. 1
D-0009-2027 1
D-0028-2027 1
- Recalling firm
- Carolina Infusion, LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Lack of Assurance of Sterility: Related to formulation using bacteriostic water, Related to processing equipment used in compounded product. 1
D-0035-2027 1
D-0005-2027 1
D-0029-2027 1
- Recalling firm
- Carolina Infusion, LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Lack of Assurance of Sterility: Related to formulation using bacteriostic water, Related to processing equipment used in compounded product. 1
D-0012-2027 1
N/A 1
- Recalling firm
- Centric Compounding LLC 1
- Product type
- Drug 1
- Class
- Not Yet Classified 1
- Status
- Ongoing 1
- Recall started
- 27 July 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. 1
D-0017-2027 1
- Recalling firm
- Carolina Infusion, LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Lack of Assurance of Sterility: Related to formulation using bacteriostic water, Related to processing equipment used in compounded product. 1
D-0002-2027 1
D-0026-2027 1
- Recalling firm
- Carolina Infusion, LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Lack of Assurance of Sterility: Related to formulation using bacteriostic water, Related to processing equipment used in compounded product. 1
D-0033-2027 1
D-0003-2027 1
D-0019-2027 1
- Recalling firm
- Carolina Infusion, LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Lack of Assurance of Sterility: Related to formulation using bacteriostic water, Related to processing equipment used in compounded product. 1
D-0018-2027 1
- Recalling firm
- Carolina Infusion, LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Lack of Assurance of Sterility: Related to formulation using bacteriostic water, Related to processing equipment used in compounded product. 1
D-0020-2027 1
- Recalling firm
- Carolina Infusion, LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Lack of Assurance of Sterility: Related to formulation using bacteriostic water, Related to processing equipment used in compounded product. 1
D-0008-2027 1
D-0037-2027 1
D-0879-2026 1
D-0873-2026 1
D-0874-2026 1
D-0875-2026 1
- Recalling firm
- TerSera Therapeutics LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 7 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours. 1
D-0877-2026 1
D-0878-2026 1
D-0876-2026 1
D-0010-2027 1
D-0860-2026 1
D-0863-2026 1
D-0871-2026 1
D-0855-2026 1
D-0862-2026 1
D-0856-2026 1
D-0858-2026 1
D-0868-2026 1
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 28 August 2026 1
- Report date
- 30 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Defective Delivery System: Possibility of no medication in the prefilled pen. 1
D-0867-2026 1
- Recalling firm
- Macleods Pharmaceuticals Limited 1
- Product type
- Drug 1
- Class
- Class III 1
- Status
- Ongoing 1
- Recall started
- 27 August 2026 1
- Report date
- 30 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification. 1
D-0861-2026 1
D-0857-2026 1
D-0870-2026 1
D-0859-2026 1
D-0854-2026 1
D-0845-2026 1
D-0846-2026 1
D-0844-2026 1
D-0866-2026 1
D-0843-2026 1
D-0842-2026 1
D-0841-2026 1
D-0848-2026 1
- Recalling firm
- SUN PHARMA /TARO 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 23 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH). 1
D-0852-2026 1
D-0853-2026 1
D-0864-2026 1
- Recalling firm
- OurPharma LLC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 3 September 2026 1
- Report date
- 16 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry... 1
D-0835-2026 1
D-0865-2026 1
- Recalling firm
- American Regent, Inc. 1
- Product type
- Drug 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 11 August 2026 1
- Report date
- 16 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and... 1
D-0836-2026 1
- Recalling firm
- Ajanta Pharma USA Inc 1
- Product type
- Drug 1
- Class
- Class III 1
- Status
- Ongoing 1
- Recall started
- 25 August 2026 1
- Report date
- 16 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent... 1
D-0850-2026 1
- Recalling firm
- Baxter Healthcare Corporation 1
- Product type
- Drug 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 17 August 2026 1
- Report date
- 16 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution. 1
D-0869-2026 1
- Recalling firm
- B BRAUN MEDICAL INC 1
- Product type
- Drug 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 19 August 2026 1
- Report date
- 16 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene 1
D-0815-2026 1
D-0811-2026 1
D-0821-2026 1
D-0851-2026 1
- Recalling firm
- OPTIMAL BALANCE PHARMACY 1
- Product type
- Drug 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 5 August 2026 1
- Report date
- 9 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. 1
D-0813-2026 1
D-0833-2026 1
D-0840-2026 1
D-0834-2026 1
D-0849-2026 1
D-0824-2026 1
- Recalling firm
- Allies Group Inc. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 14 August 2026 1
- Report date
- 9 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. 1
D-0826-2026 1
- Recalling firm
- Allies Group Inc. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 14 August 2026 1
- Report date
- 9 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. 1
D-0812-2026 1
D-0828-2026 1
D-0807-2026 1
D-0814-2026 1
D-0808-2026 1
D-0823-2026 1
- Recalling firm
- Allies Group Inc. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 14 August 2026 1
- Report date
- 9 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. 1
D-0810-2026 1
D-0825-2026 1
- Recalling firm
- Allies Group Inc. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 14 August 2026 1
- Report date
- 9 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. 1
D-0817-2026 1
D-0829-2026 1
D-0806-2026 1
D-0822-2026 1
D-0809-2026 1
D-0820-2026 1
D-0819-2026 1
D-0837-2026 1
D-0838-2026 1
- Recalling firm
- Chiesi USA, Inc. 1
- Product type
- Drug 1
- Class
- Class III 1
- Status
- Ongoing 1
- Recall started
- 19 August 2026 1
- Report date
- 9 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Failed Stability Specifications: Out of specification stability result for the protein concentration profile. 1
D-0839-2026 1
- Recalling firm
- Mylan Pharmaceuticals Inc 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 17 August 2026 1
- Report date
- 9 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Failed Dissolution Specifications, product failed to meet 18-month stability testing acceptance criteria 1
D-0818-2026 1
D-0805-2026 1
D-0816-2026 1
D-0830-2026 1
D-0847-2026 1
- Recalling firm
- Golden State Medical Supply Inc. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 21 August 2026 1
- Report date
- 9 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution 1
D-0785-2026 1
D-0831-2026 1
- Recalling firm
- Hikma Pharmaceuticals USA INC. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 24 August 2026 1
- Report date
- 2 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). 1
D-0776-2026 1
D-0781-2026 1
D-0775-2026 1
D-0782-2026 1
D-0789-2026 1
D-0786-2026 1
D-0777-2026 1
D-0803-2026 1
D-0783-2026 1
D-0790-2026 1
- Recalling firm
- Church & Dwight Co., Inc. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 August 2026 1
- Report date
- 2 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- CGMP Deviations, FDA inspection of the contract manufacturer noted out of limit results for microbiological testing 1
D-0784-2026 1
D-0827-2026 1
- Recalling firm
- Fresenius Kabi USA, LLC 1
- Product type
- Drug 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 10 August 2026 1
- Report date
- 2 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. 1
D-0832-2026 1
D-0779-2026 1
D-0778-2026 1
D-0780-2026 1
D-0804-2026 1
- Recalling firm
- Apotex Corp. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 13 August 2026 1
- Report date
- 2 September 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Failed Dissolution Specifications, product failed to meet 24-month stability testing acceptance criteria 1
D-0793-2026 1
- Recalling firm
- American Regent, Inc. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 24 July 2026 1
- Report date
- 26 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde 1
D-0771-2026 1
D-0799-2026 1
- Recalling firm
- American Regent, Inc. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 24 July 2026 1
- Report date
- 26 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde 1
D-0797-2026 1
- Recalling firm
- American Regent, Inc. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 24 July 2026 1
- Report date
- 26 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde 1
D-0800-2026 1
- Recalling firm
- American Regent, Inc. 1
- Product type
- Drug 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 24 July 2026 1
- Report date
- 26 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde 1
D-0796-2026 1
- Recalling firm
- American Regent, Inc. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 24 July 2026 1
- Report date
- 26 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde 1
D-0764-2026 1
- Recalling firm
- Shilpa Medicare Limited 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 29 July 2026 1
- Report date
- 26 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials 1
D-0795-2026 1
- Recalling firm
- American Regent, Inc. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 24 July 2026 1
- Report date
- 26 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde 1
D-0767-2026 1
D-0791-2026 1
- Recalling firm
- American Regent, Inc. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 24 July 2026 1
- Report date
- 26 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde 1
D-0774-2026 1
D-0765-2026 1
- Recalling firm
- Shilpa Medicare Limited 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 29 July 2026 1
- Report date
- 26 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials 1
D-0802-2026 1
- Recalling firm
- American Regent, Inc. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 24 July 2026 1
- Report date
- 26 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde 1
D-0794-2026 1
- Recalling firm
- American Regent, Inc. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 24 July 2026 1
- Report date
- 26 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde 1
D-0798-2026 1
- Recalling firm
- American Regent, Inc. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 24 July 2026 1
- Report date
- 26 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde 1
D-0788-2026 1
- Recalling firm
- Fresenius Kabi USA, LLC 1
- Product type
- Drug 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 4 August 2026 1
- Report date
- 26 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. 1
D-0770-2026 1
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 3 August 2026 1
- Report date
- 26 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- CGMP Deviations, black spots found on tablets from burnt excipient during manufacturing 1
D-0792-2026 1
- Recalling firm
- American Regent, Inc. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 24 July 2026 1
- Report date
- 26 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde 1
D-0801-2026 1
- Recalling firm
- American Regent, Inc. 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 24 July 2026 1
- Report date
- 26 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde 1
D-0769-2026 1
- Recalling firm
- Buy-Herbal 1
- Product type
- Drug 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 21 March 2026 1
- Report date
- 19 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine. 1
D-0759-2026 1
D-0755-2026 1
D-0772-2026 1
- Recalling firm
- Victory Medical Center Pharmacy 1
- Product type
- Drug 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 1 July 2026 1
- Report date
- 19 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. 1
D-0747-2026 1
D-0748-2026 1
D-0773-2026 1
- Recalling firm
- Liebel-Flarsheim Company LLC 1
- Product type
- Drug 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 31 July 2026 1
- Report date
- 19 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. 1
D-0768-2026 1
- Recalling firm
- Heritage Pharmaceuticals Inc 1
- Product type
- Drug 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 30 July 2026 1
- Report date
- 19 August 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles. 1
D-0753-2026 1
D-0749-2026 1
D-0752-2026 1
D-0766-2026 1
D-0757-2026 1
D-0756-2026 1
D-0751-2026 1
D-0760-2026 1
D-0761-2026 1
D-0750-2026 1
D-0746-2026 1
D-0754-2026 1
D-0787-2026 1
D-0763-2026 1
Z-0232-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0243-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0258-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0211-2027 1
Z-0231-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0127-2027 1
- Recalling firm
- Ventec Life Systems, Inc. 1
- Product type
- Device 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 17 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. 1
Z-0197-2027 1
- Recalling firm
- Medtronic Navigation, Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the... 1
Z-0281-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 9 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. 1
Z-0132-2027 1
- Recalling firm
- Ventec Life Systems, Inc. 1
- Product type
- Device 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 17 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. 1
Z-0229-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0196-2027 1
- Recalling firm
- Medtronic Navigation, Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the... 1
Z-0275-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 9 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. 1
Z-0131-2027 1
- Recalling firm
- Ventec Life Systems, Inc. 1
- Product type
- Device 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 17 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. 1
Z-0200-2027 1
Z-0265-2027 1
- Recalling firm
- Medtronic MiniMed, Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 2 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure... 1
Z-0206-2027 1
- Recalling firm
- TECHNO-PATH MANUFACTURING LTD. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 14 August 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional... 1
Z-0201-2027 1
- Recalling firm
- Beckman Coulter, Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 21 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifugation run... 1
Z-0260-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0267-2027 1
- Recalling firm
- Medtronic Neuromodulation 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 8 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in... 1
Z-0194-2027 1
- Recalling firm
- Medtronic Navigation, Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the... 1
Z-0227-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0237-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0259-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0233-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0278-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 9 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. 1
Z-0226-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0244-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0262-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0263-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0238-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0241-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0223-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0203-2027 1
- Recalling firm
- Medtronic MiniMed, Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 11 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by... 1
Z-0128-2027 1
- Recalling firm
- Ventec Life Systems, Inc. 1
- Product type
- Device 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 17 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. 1
Z-0225-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0277-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 9 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. 1
Z-0240-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0192-2027 1
- Recalling firm
- Think Surgical, Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 20 August 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling. 1
Z-0247-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0234-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0193-2027 1
Z-0228-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0198-2027 1
- Recalling firm
- Axonics, Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 15 July 2024 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Retroactively Reported: 10mL luer lock syringes included in kit may leak, break or experience other issues that may pose a risk to users. 1
Z-0257-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0272-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 9 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. 1
Z-0199-2027 1
- Recalling firm
- Philips North America 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of... 1
Z-0126-2027 1
- Recalling firm
- Ventec Life Systems, Inc. 1
- Product type
- Device 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 17 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. 1
Z-0283-2027 1
- Recalling firm
- AVID Medical, Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 8 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications. 1
Z-0256-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0280-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 9 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. 1
Z-0123-2027 1
- Recalling firm
- Ventec Life Systems, Inc. 1
- Product type
- Device 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 17 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. 1
Z-0239-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0195-2027 1
- Recalling firm
- Medtronic Navigation, Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the... 1
Z-0125-2027 1
- Recalling firm
- Ventec Life Systems, Inc. 1
- Product type
- Device 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 17 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. 1
Z-0250-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0249-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0152-2027 1
- Recalling firm
- Philips Ultrasound, LLC 1
- Product type
- Device 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 24 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable... 1
Z-0254-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0253-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0130-2027 1
- Recalling firm
- Ventec Life Systems, Inc. 1
- Product type
- Device 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 17 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. 1
Z-0205-2027 1
- Recalling firm
- TECHNO-PATH MANUFACTURING LTD. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 14 August 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional... 1
Z-0245-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0248-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0270-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 9 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. 1
Z-0191-2027 1
Z-0202-2027 1
- Recalling firm
- Beckman Coulter, Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 21 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break into multiple... 1
Z-0282-2027 1
- Recalling firm
- AVID Medical, Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 8 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications. 1
Z-0242-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0279-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 9 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. 1
Z-0251-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0273-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 9 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. 1
Z-0246-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0261-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0252-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0271-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 9 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. 1
Z-0204-2027 1
Z-0264-2027 1
- Recalling firm
- restor3d Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 4 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization. 1
Z-0274-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 9 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. 1
Z-0230-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0235-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0268-2027 1
- Recalling firm
- Solstice Corporation 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 22 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material. 1
Z-0266-2027 1
- Recalling firm
- Medtronic Neuromodulation 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 8 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in... 1
Z-0129-2027 1
- Recalling firm
- Ventec Life Systems, Inc. 1
- Product type
- Device 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 17 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. 1
Z-0133-2027 1
- Recalling firm
- Ventec Life Systems, Inc. 1
- Product type
- Device 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 17 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. 1
Z-0276-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 9 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. 1
Z-0236-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0124-2027 1
- Recalling firm
- Ventec Life Systems, Inc. 1
- Product type
- Device 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 17 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. 1
Z-0224-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0207-2027 1
- Recalling firm
- TECHNO-PATH MANUFACTURING LTD. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 14 August 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional... 1
Z-0269-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 9 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. 1
Z-0122-2027 1
- Recalling firm
- Ventec Life Systems, Inc. 1
- Product type
- Device 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 17 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. 1
Z-0255-2027 1
- Recalling firm
- Boston Scientific Cork, Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 28 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and... 1
Z-0164-2027 1
- Recalling firm
- Howmedica Osteonics Corp. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute... 1
Z-0145-2027 1
- Recalling firm
- Ferno-Washington Inc 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 28 April 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not... 1
Z-0166-2027 1
- Recalling firm
- Howmedica Osteonics Corp. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute... 1
Z-0176-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 2 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or... 1
Z-0002-2027 1
- Recalling firm
- Instrumentation Laboratory 1
- Product type
- Device 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 3 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. 1
Z-0163-2027 1
- Recalling firm
- Cook Incorporated 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing... 1
Z-0138-2027 1
- Recalling firm
- Medtronic Sofamor Danek USA Inc 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 12 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the... 1
Z-0189-2027 1
Z-0184-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which... 1
Z-0178-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 2 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or... 1
Z-0172-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 2 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or... 1
Z-0162-2027 1
Z-0151-2027 1
- Recalling firm
- Baxter Healthcare Corporation 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 14 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap... 1
Z-0160-2027 1
Z-0183-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which... 1
Z-0177-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 2 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or... 1
Z-0170-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 2 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or... 1
Z-0174-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 2 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or... 1
Z-0137-2027 1
- Recalling firm
- Medtronic Sofamor Danek USA Inc 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 12 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the... 1
Z-0150-2027 1
- Recalling firm
- BioFire Diagnostics, LLC 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 12 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results 1
Z-0001-2027 1
- Recalling firm
- Instrumentation Laboratory 1
- Product type
- Device 1
- Class
- Class I 1
- Status
- Ongoing 1
- Recall started
- 3 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. 1
Z-0186-2027 1
- Recalling firm
- INTELERAD MEDICAL SYSTEMS INCORPORATED 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 5 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Following a Chromium-based web-browser, report and displayed images may not match. 1
Z-0165-2027 1
- Recalling firm
- Howmedica Osteonics Corp. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute... 1
Z-0175-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 2 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or... 1
Z-0185-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which... 1
Z-0190-2027 1
- Recalling firm
- Radiometer Medical ApS 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 18 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples... 1
Z-0141-2027 1
- Recalling firm
- Cadwell Industries Inc 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 18 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient... 1
Z-0146-2027 1
Z-0157-2027 1
- Recalling firm
- In2bones USA, LLC 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 9 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws. 1
Z-0179-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 2 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or... 1
Z-0161-2027 1
Z-0136-2027 1
- Recalling firm
- Jenavalve Technology Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 July 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. 1
Z-0154-2027 1
- Recalling firm
- Steris Corporation 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 21 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may... 1
Z-0159-2027 1
- Recalling firm
- Microgenics Corporation 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 17 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH)... 1
Z-0158-2027 1
Z-0135-2027 1
- Recalling firm
- Jenavalve Technology Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 July 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. 1
Z-0153-2027 1
- Recalling firm
- Ethicon, LLC 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 8 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if... 1
Z-0171-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 2 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or... 1
Z-0156-2027 1
- Recalling firm
- Steris Corporation 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 21 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may... 1
Z-0147-2027 1
- Recalling firm
- INTEGRATED MEDCRAFT LLC 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 25 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad... 1
Z-0149-2027 1
- Recalling firm
- BioFire Diagnostics, LLC 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 12 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results 1
Z-0169-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 2 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or... 1
Z-0182-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which... 1
Z-0144-2027 1
- Recalling firm
- Sarnova HC, Llc 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 12 June 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula. 1
Z-0181-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which... 1
Z-0139-2027 1
- Recalling firm
- Becton Dickinson & Co. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 13 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature. 1
Z-0188-2027 1
- Recalling firm
- Healthmark Industries Co., Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 7 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated. 1
Z-0187-2027 1
- Recalling firm
- Merit Medical Systems, Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 27 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use. 1
Z-0168-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 2 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or... 1
Z-0180-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which... 1
Z-0134-2027 1
- Recalling firm
- Jenavalve Technology Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 July 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. 1
Z-0140-2027 1
- Recalling firm
- Becton Dickinson & Co. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 13 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature. 1
Z-0167-2027 1
- Recalling firm
- Howmedica Osteonics Corp. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 16 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute... 1
Z-0148-2027 1
- Recalling firm
- BioFire Diagnostics, LLC 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 12 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results 1
Z-0143-2027 1
- Recalling firm
- Boston Scientific Corporation 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 10 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device... 1
Z-0173-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 2 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or... 1
Z-0142-2027 1
- Recalling firm
- Neuronetics, Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 24 August 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly. 1
Z-0155-2027 1
- Recalling firm
- Steris Corporation 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 21 September 2026 1
- Report date
- 21 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may... 1
Z-0085-2027 1
- Recalling firm
- Stryker Sustainability Solutions 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 18 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate... 1
Z-0074-2027 1
- Recalling firm
- Steris Corporation 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles... 1
Z-0088-2027 1
- Recalling firm
- Medtronic MiniMed, Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 20 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test... 1
Z-0078-2027 1
- Recalling firm
- PHILIPS MEDICAL SYSTEMS 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 21 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system... 1
Z-0087-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 14 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame... 1
Z-0091-2027 1
Z-0089-2027 1
- Recalling firm
- Nihon Kohden America LLC 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 8 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of... 1
Z-0081-2027 1
- Recalling firm
- Safeguard US Operating LLC 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 2 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation... 1
Z-0070-2027 1
- Recalling firm
- Steris Corporation 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles... 1
Z-0073-2027 1
- Recalling firm
- Steris Corporation 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles... 1
Z-0080-2027 1
Z-0072-2027 1
- Recalling firm
- Steris Corporation 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles... 1
Z-0098-2027 1
Z-0071-2027 1
- Recalling firm
- Steris Corporation 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles... 1
Z-0094-2027 1
Z-0090-2027 1
Z-0096-2027 1
Z-0118-2027 1
- Recalling firm
- Steris Corporation 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 23 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could... 1
Z-0103-2027 1
Z-0109-2027 1
- Recalling firm
- Mindray DS USA, Inc. 1
- Product type
- Device 1
- Class
- Class III 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions 1
Z-0092-2027 1
Z-0075-2027 1
- Recalling firm
- Steris Corporation 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles... 1
Z-0086-2027 1
- Recalling firm
- Medline Industries, LP 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 14 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame... 1
Z-0105-2027 1
Z-0106-2027 1
Z-0110-2027 1
- Recalling firm
- Mindray DS USA, Inc. 1
- Product type
- Device 1
- Class
- Class III 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions 1
Z-0093-2027 1
Z-0069-2027 1
- Recalling firm
- Medical Action Industries, Inc. 306 1
- Product type
- Device 1
- Class
- Class III 1
- Status
- Ongoing 1
- Recall started
- 9 July 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027. 1
Z-0104-2027 1
Z-0112-2027 1
- Recalling firm
- Mindray DS USA, Inc. 1
- Product type
- Device 1
- Class
- Class III 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions 1
Z-0079-2027 1
- Recalling firm
- Cardinal Health 200, LLC 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 19 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter... 1
Z-0083-2027 1
- Recalling firm
- Beckman Coulter Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 2 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry... 1
Z-0107-2027 1
- Recalling firm
- POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 25 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to... 1
Z-0101-2027 1
Z-0111-2027 1
- Recalling firm
- Mindray DS USA, Inc. 1
- Product type
- Device 1
- Class
- Class III 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions 1
Z-0095-2027 1
Z-0077-2027 1
- Recalling firm
- GRI Medical & Electronic Technology Co., Ltd. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 26 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter 1
Z-0108-2027 1
- Recalling firm
- Canon Medical System, USA, INC. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 26 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a... 1
Z-0084-2027 1
- Recalling firm
- Beckman Coulter Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 2 September 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry... 1
Z-0115-2027 1
- Recalling firm
- Mindray DS USA, Inc. 1
- Product type
- Device 1
- Class
- Class III 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions 1
Z-0113-2027 1
- Recalling firm
- Mindray DS USA, Inc. 1
- Product type
- Device 1
- Class
- Class III 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions 1
Z-0099-2027 1
Z-0076-2027 1
Z-0119-2027 1
- Recalling firm
- Intellijoint Surgical, Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 28 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery... 1
Z-0082-2027 1
Z-0116-2027 1
- Recalling firm
- Mindray DS USA, Inc. 1
- Product type
- Device 1
- Class
- Class III 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions 1
Z-0117-2027 1
- Recalling firm
- LeMaitre Vascular, Inc. 1
- Product type
- Device 1
- Class
- Class II 1
- Status
- Ongoing 1
- Recall started
- 28 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing. 1
Z-0097-2027 1
Z-0102-2027 1
Z-0114-2027 1
- Recalling firm
- Mindray DS USA, Inc. 1
- Product type
- Device 1
- Class
- Class III 1
- Status
- Ongoing 1
- Recall started
- 31 August 2026 1
- Report date
- 14 October 2026 1
- Voluntary or mandated
- Voluntary: Firm initiated 1
- Reason given
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions 1
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