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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Mar 25, 2024 AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors... Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to ... Class I SonarMed Inc
Mar 21, 2024 AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor ... The failure to detect the partial obstruction in a 2.5mm sensor. Class I SonarMed Inc
Mar 21, 2024 AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor ... The failure to detect the partial obstruction in a 2.5mm sensor. Class I SonarMed Inc
Mar 21, 2024 AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor ... The failure to detect the partial obstruction in a 2.5mm sensor. Class I SonarMed Inc
Apr 17, 2017 SonarMed AirWave Monitor, Model Number M0001 Potential for the presence of two error codes which would make the monitor inoperable. Class II SonarMed 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.