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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Oct 13, 2013 Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needl... Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... Class II Restoration Robotics
Oct 13, 2013 ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inn... Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... Class II Restoration Robotics
Oct 13, 2013 ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Va... Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... Class II Restoration Robotics
Oct 13, 2013 Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if ster... Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... Class II Restoration Robotics

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.