Device recall
Z-0516-2025: RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit…
FDA device recall · Class II · Smith & Nephew Medical, Ltd.
Key facts
| Recall number (Z-number) | Z-0516-2025 |
|---|---|
| Recall event | 95558 |
| Product | RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials. |
| Product code | OMP |
| Recalling firm | Smith & Nephew Medical, Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K223041 |
| FEI number | 3002808194 |
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