RegWardenFDA facility compliance records
Company

Ambu A/S

7 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2016: 1 recalls; 2022: 1 recalls; 2023: 2 recalls; 2024: 1 recalls; 2025: 2 recalls1201620172018201920202021120222202312024220252026
  • Recalls (7)

Registered facilities (1)

Recalls & enforcement

  • Class IOngoing2025-07-09
    Potential for the manometer port being blocked rendering the manometer non-functional.
  • Class IIOngoing2025-04-07
    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 inside correctly states 5.6/2.8.
  • Class IIOngoing2024-09-16
    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.
  • Class IIOngoing2023-12-05
    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 lithium-ion battery and result in a fire hazard and battery …
  • Class IIOngoing2023-07-21
    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
  • Class IIOngoing2022-06-03
    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.
  • Class IITerminated2016-02-10
    Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovered the problem during final quality control at manufacturing site. Damage to the sterile barrier (the pouch) may compromise a medical device's sterility,leading to contamination of t…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Ambu A/S — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10076603-ambu-a-s/

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