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 | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump |
| Product | RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140 |
| Quantity | 675 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Chile. |
| Initiated | 2024-03-11 |
| Classified | 2024-04-18 |
| Recall number | Z-1597-2024 |
| 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-1597-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94248/
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