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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
Feb 28, 2025 Phoroptor VRx Digital Refraction System Model Numbers: 16242 The head of the phoropter head could come loose and potentially detach due to a default in the as... Class II Reichert, Inc.
Feb 28, 2025 Phoroptor VRx Digital Refraction System Model Numbers: 16241 The head of the phoropter head could come loose and potentially detach due to a default in the as... Class II Reichert, Inc.
Jul 20, 2023 PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the su... Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthal... Class II Reichert, 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.