Device recall
Z-1069-2022: 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA…
FDA device recall · Class II · Karl Storz Endoscopy
Key facts
| Recall number (Z-number) | Z-1069-2022 |
|---|---|
| Recall event | 89880 |
| Product | 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSU 11278VSUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VSUA 11278VSUAK Flexible… |
| Product code | FGB |
| Recalling firm | Karl Storz Endoscopy |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K141250 |
| FEI number | 3007475226 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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