Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0261-2025 — 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)

U.S. FDA — Device Enforcement · United States · 2024-09-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0261-2025
Date of alert
2024-09-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ambu Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
1000891667
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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