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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
Apr 20, 2020 Oscar 2, Model 250 System The device display, when activated, can show an incorrect decimal point when the blood pressure r... Class II Suntech Medical, Inc.
Dec 11, 2019 Model 250D Ambulatory Blood Pressure Monitor labeled under the following bran... The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalle... Class II Suntech Medical, Inc.
Jun 3, 2019 SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure ... Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 ... Class II Suntech Medical, 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.