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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
Nov 3, 2025 GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image proces... GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.... Class II GE Healthcare GmbH
Aug 8, 2024 ViewPoint; system, imaging processing, radiological The National Institute of Standards and Technology (NIST) has identified in the National Vulnerab... Class II GE Healthcare GmbH
Aug 8, 2024 ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591... The National Institute of Standards and Technology (NIST) has identified in the National Vulnerab... Class II GE Healthcare GmbH

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.