Drug recall
RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as…
FDA recall event 95558 · Class II · Smith & Nephew Medical, Ltd.
Key facts
| Event ID | 95558 |
|---|---|
| Recall numbers | Z-0516-2025 |
| Recalling firm | Smith & Nephew Medical, Ltd. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained. |
| Initiation date | Oct 2, 2024 |
| Report date | Dec 4, 2024 |
| City | Hull |
| Country | United Kingdom |
| FEI number | 3002808194 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: