The Recall Desk

Manufacturer

Ambu Inc.

7 recalls in our database name Ambu Inc. as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
1
Severe
0
Most recent
2025-08-20

Of the 7 recalls from Ambu Inc. we have scored against our rubric, 1 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–7 of 7

  • CriticalFDA (Devices)·Z-2181-2025·2025-08-20

    Manual resuscitators recalled because blocked manometer port may disable pressure gauge

    Ambu is recalling 87,156 SPUR II adult resuscitators because the manometer port may be blocked, leaving the manometer non-functional. The FDA classified the action as Class I.

    Product
    Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1723-2025·2025-05-14

    Ambu aScope 5 Broncho HD Endoscope Labeling Error Recall

    Ambu Inc. is recalling 160 units of the Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set due to incorrect front pouch labeling that states 5.0/2.2 instead of the correct size 5.6/2.8.

    Product
    Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0261-2025·2024-11-06

    Ambu VivaSight 2 DLT endotracheal tubes recalled for hyper angulation risk

    Ambu is recalling VivaSight 2 DLT endotracheal tubes due to hyper angulation of the distal end, which increases risk of intubation complications and airway injury.

    Product
    Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0714-2024·2024-01-17

    Ambu aView 2 Monitor recalled for fire and burn hazard from oversized mounting screws

    Ambu is recalling the aView 2 A Monitor due to fire and burn hazards if mounting screws longer than 16mm are used. Improper installation can penetrate the lithium-ion battery, causing fires, severe burns, and smoke inhalation.

    Product
    Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2023·2023-10-04

    Ambu aView 2 Advance Monitor Recalled Due to Battery Combustion Risk

    Ambu Inc. is recalling the aView 2 Advance Monitor because multiple impacts can cause the device to short-circuit and potentially combust the lithium-ion battery, resulting in smoke and flames.

    Product
    Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system. Catalog No: 405011000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1420-2022·2022-07-27

    Ambu VivaSight 2 DLT endobronchial tubes recalled for cuff leak risk

    Ambu Inc. is recalling the VivaSight 2 DLT endobronchial tube system due to reports of cuff leaks or ruptures that could compromise airway security during intubation procedures.

    Product
    Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1236-2016·2016-03-30

    Ambu Aura Gain Laryngeal Masks Recalled for Sterility Assurance Failure

    Ambu Inc. is recalling Aura Gain laryngeal masks because damage to the sterile barrier may compromise sterility, risking patient contamination.

    Product
    Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures.
    Category
    Medical Device
    Distribution
    0 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Ambu

company

Country
Denmark
Founded
1937

Official website

Source: Wikidata (Q459957), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.