Ambu Inc.

3 FDA enforcement actions

3 Total Recalls

1 Class I

2 Class II

0 Class III

Firm Details

Product Types: device
States: MD

All Recalls

Class I: Dangerous 07/09/2025 device

Potential for the manometer port being blocked rendering the manometer non-functional.
Class II: Risk 04/07/2025 device

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 II: Risk 09/16/2024 device

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.