Class II — Smith & Nephew, Inc.
| Recalling firm | Smith & Nephew (Suzhou) Limited |
|---|---|
| Registered facility | SMITH & NEPHEW (SUZHOU) LIMITED (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Lack of 510k clearance for design modification. |
| Product | Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts. |
| Quantity | 15,960 units in the US |
| Distribution | Nationwide |
| Initiated | 2016-11-11 |
| Classified | 2017-01-18 |
| Recall number | Z-1041-2017 |
| 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, Inc. (Z-1041-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75966/
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