Ambu Inc.: Device Recall

Recall #Z-0261-2025 · 09/16/2024

Class II: Risk

Recall Details

Recall Number: Z-0261-2025
Classification: Class II
Product Type: Device
Recalling Firm: Ambu Inc.
Status: Ongoing
Date Initiated: 09/16/2024
Location: Columbia, MD, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1824

Reason for Recall

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.

Product Description

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)

Distribution Pattern

US Nationwide. Canada.

Other Recalls by Ambu Inc.

Class I: Dangerous 07/09/2025

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

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.

View all recalls by Ambu Inc. →

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.