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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
May 2, 2024 GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) ... GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a ... Class II GE Vingmed Ultrasound As
May 2, 2024 GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a ... Class II GE Vingmed Ultrasound As
May 30, 2023 GE Healthcare Vivid S60, ultrasound device GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f... Class II GE Vingmed Ultrasound As
May 30, 2023 GE Healthcare Vivid S70, ultrasound device GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f... Class II GE Vingmed Ultrasound As
May 30, 2023 GE Healthcare Vivid S70N, ultrasound device GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f... Class II GE Vingmed Ultrasound As
May 30, 2023 GE Healthcare Vivid S60N, ultrasound device GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f... Class II GE Vingmed Ultrasound As

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.