Device recall
Z-1897-2025: Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and…
FDA device recall · Class II · Silex Medical, LLC
Key facts
| Recall number (Z-number) | Z-1897-2025 |
|---|---|
| Recall event | 96755 |
| Product | Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030. |
| Product code | GEI |
| Recalling firm | Silex Medical, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K914910 |
| FEI number | 3005110411 |
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