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 | Terminated |
| Reason | Modification of the bacterial overflow guard (filter) and related changes to product labeling. |
| Product | Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System |
| Quantity | 6,871,375 canisters |
| Distribution | Worldwide Distribution: USA (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NH, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV, and Puerto Rico; and the countries of: Austria, Australia, Belgium, Switzerland, China, Cyprus, Germany, Denmark, Spain, Finland, France, UK, Greece, Israel, Italy, Malta, Netherlands, Norway, Paraguay,… |
| Initiated | 2013-11-14 |
| Classified | 2014-02-21 |
| Terminated | 2014-08-04 |
| Recall number | Z-1068-2014 |
| 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-1068-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66893/
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