Device recall
Z-1067-2022: 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A…
FDA device recall · Class II · Karl Storz Endoscopy
Key facts
| Recall number (Z-number) | Z-1067-2022 |
|---|---|
| Recall event | 89880 |
| Product | 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope… |
| Product code | FGB |
| Recalling firm | Karl Storz Endoscopy |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K982905 |
| 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