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Browse Device Recalls

92 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 92 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 92 FDA device recalls.

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DateProductReasonClassFirm
Mar 31, 2016 American Surgical Ultracot 13 mm x 60 mm (Glassine) Ref Number: 23-08G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Policot 1/4" x 1/4" Ref Number: 90-02 Product Usage: N... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product Usage: N... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Produ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usag... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1/2" x 1" Ref Number: 60-07 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Strung 3/4" Ref Number: 30-03 Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product Us... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Strung 1" Ref Number: 30-04 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1/2" x 1/2" Ref Number: 60-06 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 30 mm x 70 mm Ref Number: 23-10 Product Usage... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1/4" x 1/4" Ref Number: 60-02 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan Only) ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Uniqcot 1/4" x 1/4" Ref Number: 67-02 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Ne... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Us... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: N... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Delicot X 9 mm x 50 mm Ref Number: 63x07 Product Usage: ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Produ... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neu... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usag... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usag... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neuro... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Prod... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: N... Product packaging defective compromising sterility Class II American Surgical Company
Mar 31, 2016 American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage:... Product packaging defective compromising sterility Class II American Surgical Company

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.