Device recall
Z-1068-2022: 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK…
FDA device recall · Class II · Karl Storz Endoscopy
Key facts
| Recall number (Z-number) | Z-1068-2022 |
|---|---|
| Recall event | 89880 |
| Product | 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA… |
| Product code | FGB |
| Recalling firm | Karl Storz Endoscopy |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K131369 |
| 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