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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
Jan 27, 2017 Hand Foot II, UVB-138. One device per box; device is surrounded by foam inse... The wiring may allow the lamps to turn on with the key switch rather than the timer. Class II National Biological Corp
Apr 9, 2013 Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 i... The incorrect manual may have been packaged with this product. UVB-080 devices may have included ... Class III National Biological Corp
Apr 8, 2013 Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is... The incorrect manual may have been packaged with this product. UVB-083 devices may have included... Class III National Biological 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.