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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Dec 1, 2014 EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Kne... Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition wher... Class II Stelkast Co
Jun 24, 2013 SC2316, Distal Femoral Augment with Screw Total knee replacement due to os... The firm became aware of an incident relating to a breach of sterility in the sterility barrier p... Class II Stelkast Co
Jan 24, 2013 Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC345... Firm was made aware of incidents relating to the difficulty of properly engaging and securing the... Class II Stelkast Co

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.