Reported Nov 6, 2024 · Ongoing

Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr…

Ambu Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ambu Inc. · 6721 Columbia Gateway Dr Ste 200 · Columbia, MD · 21046-3380

Is this the product you have?

    • 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)
Lot codes and dates

4 of 4 products

Products covered by this recall
#Product as published
1VivaSight 2 DLT Kit 35 Fr - lot no. 1000891667 to lot. no 1001021855
2VivaSight 2 DLT Kit 37 Fr - lot. no. 1000887909 to lot no. 1001021861
3VivaSight 2 DLT Kit 39 Fr - lot. no. 1000916871 to lot no. 1001021917
4VivaSight 2 DLT Kit 41 Fr - lot. no. 1000934084 to lot. no. 1001011434
Amount recalled
1824

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.