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Browse Device Recalls

55 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 55 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 55 FDA device recalls.

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DateProductReasonClassFirm
Feb 4, 2012 "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corpora... Ortho sensor in Sunrise, FL is recalling the Graphics User Interface Software 1.8 (which was upda... Class II Orthosensor
Jan 26, 2012 Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Pr... Stryker has become aware that there exists a potential for breach of the sterile barrier of packa... Class II Stryker Howmedica Osteonics Corp.
Dec 29, 2011 Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics ... Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle A... Class II Stryker Howmedica Osteonics Corp.
Dec 29, 2011 Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-0... Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their ... Class II Stryker Howmedica Osteonics Corp.
Dec 22, 2011 Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Ost... Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted ... Class II Stryker Howmedica Osteonics Corp.

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.