FDA Medical devices recall ·
Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR ( recall
- Recall number
- Z-0261-2025
- Date
- (initiated September 16, 2024)
- Company / brand
- Ambu
6721 Columbia Gateway Dr Ste 200, Columbia, MD, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1824
- Hazard tags
- Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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)
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
US Nationwide. Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0261-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.