Device recall
Z-0798-2020: ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number…
FDA device recall · Class II · CooperSurgical, Inc.
Key facts
| Recall number (Z-number) | Z-0798-2020 |
|---|---|
| Recall event | 84443 |
| Product | ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera at the distal end, which… |
| Product code | HIH |
| Recalling firm | CooperSurgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 11, 2021 |
| 510(k) numbers | K190639 |
| FEI number | 1216677 |
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