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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
Mar 30, 2017 Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: T... Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" H... Class I Newport Medical Instruments Inc
Apr 5, 2013 Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batterie... Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instrumen... Class I Newport Medical Instruments Inc
Aug 3, 2012 Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. ... May emit a continuous high priority alarm and the ventilator may stop ventilating, due to a compo... Class I Newport Medical Instruments 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.