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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Dec 6, 2017 Health Harmony Mobile application software Product Usage: Care Innovatio... It was discovered that in certain situations, including partial sessions and when taking adhoc me... Class II Intel-GE Care Innovations LLC
Apr 4, 2013 QuietCare-Networked. Intended for use in monitoring the environmental cond... Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. Class II Intel-GE Care Innovations LLC
Apr 4, 2013 QuietCare. Intended for use in monitoring the environmental conditions and... Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. Class II Intel-GE Care Innovations LLC
Dec 16, 2012 QuietCare-Networked product, Facility Server/model: QC101601; The QuietCa... Care Innovations detected a software anomaly: During the engineering investigation into the cause... Class II Intel-GE Care Innovations LLC

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.