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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
Feb 2, 2016 Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for ... The firm discovered that the incorrect lot number was engraved on the product. Class III Volk Optical Inc
Feb 27, 2015 Lombart 90D Clear with case Visualization during diagnosis and laser therapy... Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct l... Class III Volk Optical Inc
Feb 27, 2015 Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL IN... Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. Class III Volk Optical Inc
Oct 25, 2012 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization ... The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed ... Class III Volk Optical 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.