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Browse Device Recalls

2 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2 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 2 FDA device recalls.

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DateProductReasonClassFirm
Feb 11, 2015 Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves... Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes label... Class II Sybron Dental Specialties
Jun 6, 2013 AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal de... The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complet... Class II Sybron Dental Specialties

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.