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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
Sep 3, 2021 ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLB... The devices malfunction under specific operator workflows. Class II Welch Allyn Inc Mortara
Mar 31, 2021 ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacte... Devices do not meet IEC 60601-2-27 requirements as labeled. Class II Welch Allyn Inc Mortara
Mar 31, 2021 ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacte... Devices do not meet IEC 60601-2-27 requirements as labeled. Class II Welch Allyn Inc Mortara
Mar 31, 2021 AM12M Acquisition Module accessory. Impacted software version of the AM12M i... Devices do not meet IEC 60601-2-27 requirements as labeled. Class II Welch Allyn Inc Mortara
Mar 31, 2021 Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module acces... Devices do not meet IEC 60601-2-27 requirements as labeled. Class II Welch Allyn Inc Mortara

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.