AMBU Limited

Country not established FDA establishment FEI 3003924186

Devices: 0
Registrations: FDA
FDA recalls: 76 ongoing

No devices from this company are in the catalogue yet.

Company details

FDA FEI number: 3003924186
Address: No.C,, XIANG YU F.T.Z., XIAMEN Fujian

FDA recalls7

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

2017 0
2018 0
2019 0
2020 0
2021 0
2022 1
2023 2
2024 1
2025 2
2026 0

1 initiated before 2017

2025
- 9 Jul 2025 Z-2181-2025 Class I Ongoing Potential for the manometer port being blocked rendering the manometer non-functional. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Submission number: K152931
- 7 Apr 2025 Z-1723-2025 Class II Ongoing 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. Submission number: K232582
2024
- 16 Sep 2024 Z-0261-2025 Class II Ongoing 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. Submission number: K203749
2023
- 5 Dec 2023 Z-0714-2024 Class II Ongoing 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. Submission number: K223299
- 21 Jul 2023 Z-2628-2023 Class II Ongoing 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
2022
- 3 Jun 2022 Z-1420-2022 Class II Ongoing 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,…
  Full distribution text
  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 Canada, Australia, New Zealand, Israel .
  Submission number: K203749
2016
- 10 Feb 2016 Z-1236-2016 Class II Terminated 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 the product and,ultimately,patient complications. Distribution: Please see attached consignee list

This is an FDA establishment record without devices in deviCERTS.