Ambu VivaSight 2 DLT endotracheal tubes recalled for hyper angulation risk
Ambu is recalling VivaSight 2 DLT endotracheal tubes due to hyper angulation of the distal end, which increases risk of intubation complications and airway injury.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves a structural defect in an airway management device with potential for airway injury. No injuries or illnesses have been reported in the source text, but the product represents a risk-of-harm category where injury has not yet been reported, meeting the High severity criterion.
Plain-English summary
Ambu Inc. is recalling specific lot codes of Ambu VivaSight 2 DLT Endobronchial tubes in four sizes (35 Fr, 37 Fr, 39 Fr, and 41 Fr). The recall affects 1824 units distributed throughout the United States and Canada.
Ambu has received complaints regarding hyper angulation of the distal end of these tubes. This structural issue can lead to increased risk of complications during intubation procedures and potential airway injury.
Healthcare facilities and personnel should verify whether they have affected lot codes in use and follow institutional protocols in consultation with Ambu regarding appropriate next steps.
The recalled product
- 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)
- Manufacturer
- Ambu Inc.
- Hazard
- airway-injury
- intubation-complication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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
Distributed nationwide across the United States.
Related recalls
Same category
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27