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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.

Clear
DateProductReasonClassFirm
Nov 17, 2021 Senior Living Arial Emergency and Nurse Call Systems Systems are not alarming due to increased memory consumption. Class II Stanley Security Solutions Inc
Jun 14, 2019 STANLEY Healthcare Arial 54315 Network Manager STANLEY Healthcare has received reports of outages on the Arial nurse call system. These outages... Class II Stanley Security Solutions Inc
Oct 11, 2018 M200 Fall Monitoring System Damaged capacitor on the printed circuit board. Class II Stanley Security Solutions Inc
Jun 22, 2016 Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part o... Devices were incorrectly programmed during manufacturing therefore depressing the pendant button ... Class II Stanley Security Solutions 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.