Device recall
Z-0261-2025: Ambu VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr…
FDA device recall · Class II · Ambu Inc.
Key facts
| Recall number (Z-number) | Z-0261-2025 |
|---|---|
| Recall event | 95454 |
| 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) |
| Product code | CBI |
| Recalling firm | Ambu Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K203749 |
| FEI number | 1121788 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database