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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Feb 28, 2014 Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound i... A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will r... Class II Philips Medical Systems North America Inc.
Feb 28, 2014 Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound i... A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will r... Class II Philips Medical Systems North America Inc.
Feb 6, 2014 Philips HeartStart Home and OnSite (HS1) automated external defibrillators (A... Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) be... Class II Philips Medical Systems North America Inc.
Feb 6, 2014 Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 ... Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed C... Class II Philips Medical Systems North America Inc.
Oct 17, 2013 EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagn... A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and... Class II Philips Medical Systems North America 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.