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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 10, 2018 ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the fo... ProSun International LLC discovered discrepancies in their Quality Control Checklist documentatio... Class II ProSun International, LLC
Dec 10, 2018 ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled a... ProSun International LLC discovered discrepancies in their Quality Control Checklist documentatio... Class II ProSun International, LLC
Dec 2, 2017 Sundream 12 V tanning bed The 30 minute maximum tanning time has been reduced to 20 minutes. Class II ProSun International, LLC

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.