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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
May 30, 2025 Servo-u MR Ventilator System. Model Number: 6888800. Potential for inaccurate measurement of the patient circuit compliance during the patient circuit... Class I Maquet Critical Care AB
May 30, 2025 Servo-n Ventilator System. Model Number: 6694800. Potential for inaccurate measurement of the patient circuit compliance during the patient circuit... Class I Maquet Critical Care AB
May 30, 2025 Servo-u Ventilator System. Model Number: 6688600. Potential for inaccurate measurement of the patient circuit compliance during the patient circuit... Class I Maquet Critical Care AB
Jul 20, 2022 Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694... Ventilators may generate a combination of alarms which may result in loss of communication, techn... Class I Getinge Usa Sales Inc
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

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.