Device recall
Z-2236-2010: Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1…
FDA device recall · Class II · Olympus America Inc.
Key facts
| Recall number (Z-number) | Z-2236-2010 |
|---|---|
| Recall event | 55663 |
| Product | Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube model numbers: MAJ-13 and MAJ-15. To be used with Olympus endoscopes to electrosurgically resect tissue within the digestive tract. |
| Product code | FDI |
| Recalling firm | Olympus America Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 20, 2013 |
| 510(k) numbers | K955650 |
| FEI number | 2429304 |
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