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Browse Device Recalls

54 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 54 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 54 FDA device recalls.

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DateProductReasonClassFirm
Apr 8, 2013 Endopath Electrosurgery Probe Plus II, twelve (12) different devices, includi... The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in th... Class II Ethicon Endo-Surgery Inc
Nov 6, 2012 Ethicon Endo-Surgery Inc. The ENSEAL¿ G2 Tissue Sealers are indicated for bip... Potential for self activation while the device is in use, which may result in unintended thermal ... Class II Ethicon Endo-Surgery Inc
Oct 4, 2012 PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routi... Damage to the packaging may have compromised the sterility of the device. Class II Ethicon Endo-Surgery Inc
Aug 3, 2012 Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: ... Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXI... Class I Ethicon Endo-Surgery 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.