Ambu Inc.: Medical Device Recall in 2024 - (Recall #: Z-0261-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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)

Product Classification:

Class II

Date Initiated: September 16, 2024

Date Posted: November 6, 2024

Recall Number: Z-0261-2025

Event ID: 95454

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.

Status: Ongoing

Product Quantity: 1824

Code Information:

Lot Codes: VivaSight 2 DLT Kit 35 Fr - lot no. 1000891667 to lot. no 1001021855; VivaSight 2 DLT Kit 37 Fr - lot. no. 1000887909 to lot no. 1001021861; VivaSight 2 DLT Kit 39 Fr - lot. no. 1000916871 to lot no. 1001021917; VivaSight 2 DLT Kit 41 Fr - lot. no. 1000934084 to lot. no. 1001011434

Distribution Pattern:

US Nationwide. Canada.

Voluntary or Mandated:

Voluntary: Firm initiated