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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
Aug 27, 2025 The AlignRT InBore system contains six Class 1 lasers which enables the syste... Vision RT is informing customers of an omission identified in the Instructions for Use for AlignR... Class II Vision RT Ltd
Aug 24, 2018 Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant... RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB Class II Vision RT Ltd
Jun 30, 2016 AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indic... Vision RT Ltd received three (3) reports from different sites that discovered the following issue... Class II Vision RT Ltd
Jun 30, 2016 TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System... Vision RT Ltd received three (3) reports from different sites that discovered the following issue... Class II Vision RT Ltd

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.