Ambu¿ VivaSight 2 DLT Endobronchial tube — Class II medical device recall Z-0261-2025
Ongoing recall by Ambu Inc., reported 2024-11-06, distributed nationwide. Ambu has received complaints on Ambu¿ VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper
| Recall number | Z-0261-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ambu Inc., Columbia, MD, United States |
| Recall initiated | 2024-09-16 |
| Classified | 2024-10-30 |
| Reported by FDA | 2024-11-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,824 |
| Lot numbers | 1000887909, 1000891667, 1000916871, 1000934084, 1001011434, 1001021855, 1001021861, 1001021917 |
| Model numbers | 412351000, 412371000, 412391000, 412411000 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0261-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.