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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 28, 2016 Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved... The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate c... Class II Integra York PA, Inc
Oct 28, 2016 Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pea... The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate c... Class II Integra York PA, Inc
Mar 11, 2016 Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manu... One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may ... Class II Integra York PA, Inc
Jul 30, 2014 Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container ... Integra LifeSciences has identified through an internal investigation that some colored lids for ... Class II Integra York PA, 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.