RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product… — Class II medical device recall Z-0039-2015
Terminated recall by Smith & Nephew, Inc., reported 2014-10-15, distributed nationwide. RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
| Recall number | Z-0039-2015 |
|---|---|
| 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 | 2014-07-18 |
| Classified | 2014-10-08 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2015-08-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CO, DE, HK, LB, MX, MY, NZ, SA, TH, TN, ZA |
| Lot numbers | M400021, M400067 |
| Model numbers | 66800058, 66800913 |
Product
RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Reason for recall
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
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-0039-2015. 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.