Device recall
Z-1362-2026: Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784…
FDA device recall · Class II · Wilson-Cook Medical Inc.
Key facts
| Recall number (Z-number) | Z-1362-2026 |
|---|---|
| Recall event | 98202 |
| Product | Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in… |
| Product code | KNS |
| Recalling firm | Wilson-Cook Medical Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K243568 |
| FEI number | 1037905 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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