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
Feb 11, 2021 Operating Table System There is a potential for hydraulic leakage at the inclination function to occur resulting in an u... Class II Getinge Group Logistics America, LLC
Jan 29, 2021 Anesthesia gas-machine - Product Usage: intended for use in administering ane... Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zer... Class II Getinge Group Logistics America, LLC
Dec 21, 2020 Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber wash... The potential that the plastic inlet hose connections may deform or break as a result of material... Class II Getinge Group Logistics America, LLC
Sep 17, 2020 Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage... A potentially shorter than specified nebulizer connector may result in difficulty in installing t... Class II Getinge Group Logistics America, LLC

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.