FDA recall Z-0261-2025

Product

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)

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.

Distribution

US Nationwide. Canada.

Key facts

Status

Ongoing

Initiation date

2024-09-16

Report date

2024-11-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbia, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0261-2025