Class II — Smith & Nephew Medical, Ltd.
| Recalling firm | SMITH AND NEPHEW MEDICAL LTD. |
|---|---|
| Registered facility | Smith & Nephew Medical Ltd (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained. |
| 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. |
| Quantity | 1589 units |
| Distribution | U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: Canada |
| Initiated | 2024-10-02 |
| Classified | 2024-11-22 |
| Recall number | Z-0516-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Smith & Nephew Medical, Ltd. (Z-0516-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95558/
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