Columbia, MD, United States
Ambu Inc. recalls
6 recalls recorded since 2018, most recently on 9 July 2025. 6 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)6
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 9 July 2025
- Reason
- Potential for the manometer port being blocked rendering the manometer non-functional.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2181-2025
- 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 P
Ongoing Class II Medical devices
- Recall started
- 7 April 2025
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1723-2025
- Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Ongoing Class II Medical devices
- Recall started
- 16 September 2024
- Reason
- 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.
- Distribution
- US Nationwide. Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0261-2025
- 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)
Ongoing Class II Medical devices
- Recall started
- 5 December 2023
- Reason
- 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 leakage which can cause severe burns, smoke inhalation and skin irritation. Using shorter screw lengths could result in unsecure device fastening.
- Distribution
- Domestic distribution nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0714-2024
- Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Ongoing Class II Medical devices
- Recall started
- 21 July 2023
- Reason
- 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
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2628-2023
- 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
Ongoing Class II Medical devices
- Recall started
- 3 June 2022
- Reason
- 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.
- Distribution
- Domestic distribution nationwide. Foreign distribution to Austria, Belgium, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norge, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, UK C
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1420-2022
- Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.