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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Jul 9, 2025 Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, C... Potential for the manometer port being blocked rendering the manometer non-functional. Class I Ambu Inc.
Apr 7, 2025 Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US Incorrect labeling in which the front red pouch label did not match the actual size of the medica... Class II Ambu Inc.
Sep 16, 2024 Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 3... Ambu has received complaints on Ambu¿ VivaSight 2 DLTs regarding hyper angulation of the distal e... Class II Ambu Inc.
Dec 5, 2023 Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 Instructions for Use have been updated to add the following warning: Use only M4 screws with the ... Class II Ambu Inc.
Jul 21, 2023 Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live i... Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-... Class II Ambu Inc.
Jun 3, 2022 Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube place... Firm has received complaints on the device concerning leak/rupture of either the bronchial or tra... Class II Ambu Inc.
Feb 10, 2016 Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternat... Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovere... Class II Ambu 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.