RENASYS EZ Negative Pressure Wound Therapy — Class II medical device recall Z-2688-2014
Terminated recall by Smith & Nephew, Inc., reported 2014-10-01, distributed nationwide. Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
| Recall number | Z-2688-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Saint Petersburg, FL, United States |
| Recall initiated | 2014-08-13 |
| Classified | 2014-09-23 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2015-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CL, CO, DE, ES, FR, GB, HK, IT, JP, MX, NO, NZ, SG, TH, ZA |
| Quantity | 2,142 units |
| Model numbers | 66800059 |
Product
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.
Reason for recall
Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
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-2688-2014. 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.