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Browse Device Recalls

2 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2 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 2 FDA device recalls.

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DateProductReasonClassFirm
Nov 12, 2020 Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compr... Under certain conditions, there is a risk for fire. Class II Hill-Rom Manufacturing, Inc.
Sep 15, 2017 Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has b... Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or i... Class II HILL-ROM MANUFACTURING, 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.