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 | RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. |
| Product | RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) 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). |
| Quantity | 45,466 |
| Distribution | Worldwide Distribution - US Nationwide in the states of FL, NC, CA, MO, MA, TX, NY, OH, CO, VA, IL, NJ, TN, NV, MN including Puerto Rico and countries of Canada, Mexico, Dubai, Argentina, Australia, Colombia, Germany, Hong Kong, Jordon, Malaysia, Thailand, Tunisia, New Zealand, South Africa, Shanghai, Brazil, Saudi Arabia and Lebanon. |
| Initiated | 2014-07-18 |
| Classified | 2014-10-08 |
| Terminated | 2015-08-05 |
| Recall number | Z-0041-2015 |
| 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-0041-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69146/
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