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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Jan 3, 2023 FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloop... Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, bu... Class III Owens & Minor Distribution, Inc.
Oct 31, 2022 Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734 Potential open seal pouches compromising sterility resulting in the use of a non-sterile product ... Class II Owens & Minor Distribution, Inc.
Oct 31, 2016 Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2... Owens & Minor is the initial importer and private label distributor of Medi Choice Arm Slings (Pr... Class II Owens & Minor Distribution, Inc.
Nov 17, 2015 MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirt... MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor wer... Class II Owens & Minor Distribution, Inc.
Nov 17, 2015 MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirt... MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor wer... Class II Owens & Minor Distribution, Inc.
Nov 17, 2015 MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirt... MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor wer... Class II Owens & Minor Distribution, Inc.
Jun 25, 2014 MediChoice Dual-Release Folding Walker with 5" wheel Product wheels may be too loose, too tight, or fall off. Class II Owens & Minor Distribution, Inc.
Mar 26, 2013 MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Steril... Owens & Minor Distribution, Inc. is conducting a market withdrawal of MediChoice Applicator OB-GY... Class II Owens & Minor Distribution, Inc.

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.