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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
Mar 17, 2020 RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single u... RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was la... Class II Rayner Intraocular Lenses Limited
Aug 9, 2018 C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designe... Firm become aware of reports of post-operative refractive errors following implantation of lenses. Class II Rayner Intraocular Lenses Limited

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.