Class II — Ambu Inc.
| Recalling firm | Ambu A/S |
|---|---|
| Registered facility | AMBU INNOVATION GMBH (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| 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) |
| Quantity | 1824 |
| Distribution | US Nationwide. Canada. |
| Initiated | 2024-09-16 |
| Classified | 2024-10-30 |
| Recall number | Z-0261-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ambu Inc. (Z-0261-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95454/
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