Recall Atlas

Ambu recalls

6 official recalls and safety alerts involving Ambu since 2022-07, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Ambu or the relevant agency.

  1. 2025-08-20
  2. US
    Drugs & medicalClass I

    Ambu Inc. recalls Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator…

    Potential for the manometer port being blocked rendering the manometer non-functional.

    FDA · DeviceAmbu Inc.Worldwide distribution - US Nationwide and the country of Canada.Official notice →
  3. 2025-05-14
  4. US
    Drugs & medicalClass II

    Ambu Inc. recalls 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 medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product…

    FDA · DeviceAmbu Inc.US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ,…Official notice →
  5. 2024-11-06
  6. US
    Drugs & medicalClass II

    Ambu Inc. recalls Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number…

    Ambu has received complaints on Ambu¿ VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intubation and potential airway injury.

    FDA · DeviceAmbu Inc.US Nationwide. Canada.Official notice →
  7. 2024-01-17
  8. US
    Drugs & medicalClass II

    Ambu Inc. recalls 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 length of 14 16 mm when mounting Ambu aView 2 Advance on a VESA interface. Using longer screw lengths will penetrate the…

    FDA · DeviceAmbu Inc.Domestic distribution nationwide.Official notice →
  9. 2023-10-04
  10. US
    Drugs & medicalClass II

    Ambu Inc. recalls Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices,…

    Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in the device combust leading to smoke and flames

    FDA · DeviceAmbu Inc.NationwideOfficial notice →
  11. 2022-07-27
  12. US
    Drugs & medicalClass II

    Ambu Inc. recalls Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000,…

    Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require re-intubation of patient.

    FDA · DeviceAmbu Inc.Domestic distribution nationwide. Foreign distribution to Austria, Belgium,…Official notice →