Smith & Nephew — Class II medical device recall Z-1041-2017
Ongoing recall by Smith & Nephew, Inc., reported 2017-01-25, distributed nationwide. Lack of 510k clearance for design modification.
| Recall number | Z-1041-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Saint Petersburg, FL, United States |
| Recall initiated | 2016-11-11 |
| Classified | 2017-01-18 |
| Reported by FDA | 2017-01-25 |
| Distributed | Nationwide (US) |
| Quantity | 15,960 units |
| Model numbers | 66800164 |
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.
Reason for recall
Lack of 510k clearance for design modification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1041-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.