Renasys EZ PLUS — Class II medical device recall Z-1068-2014
Terminated recall by Smith & Nephew Inc., reported 2014-03-05, distributed nationwide. Modification of the bacterial overflow guard (filter) and related changes to product labeling.
| Recall number | Z-1068-2014 |
|---|---|
| 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 | 2013-11-14 |
| Classified | 2014-02-21 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2014-08-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CN, CY, DE, DK, ES, FI, FR, GB, GR, IL, IT, MT, MX, NL, NO, PY, RU, SA, SE, TH, TR, ZA |
| Quantity | 6,871,375 canisters |
| Reason classes | microbial contamination, labeling |
| Lot numbers | M201498 |
Product
Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
Reason for recall
Modification of the bacterial overflow guard (filter) and related changes to product labeling.
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-1068-2014. 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.