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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
Aug 9, 2024 Vios Monitoring System Bedside Monitor Model BSM2050 Batteries may deplete over time while not in use if devices are stored without being plugged in t... Class II Murata Vios, Inc.
Apr 22, 2024 muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including ... During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital s... Class II Murata Vios, Inc.
Jun 6, 2023 Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbe... A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that conn... Class II Murata Vios, Inc.
Jun 21, 2021 muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including ... During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital s... Class II Murata Vios, 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.