Device recall
Z-2413-2026: Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-2413-2026 |
|---|---|
| Recall event | 98970 |
| Product | Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure. |
| Product code | ODC |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K252910 |
| FEI number | 3005099803 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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