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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
Jul 27, 2016 CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's v... A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time dat... Class II INNOKAS MEDICAL OY
Oct 22, 2015 CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans Monitor may shut down unintentionally without restarting. Class II Innokas Medical Oy
Dec 3, 2014 VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique ... If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to moni... Class II INNOKAS MEDICAL OY

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.