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 were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification. |
| 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. |
| Quantity | 2,142 units |
| Distribution | Worldwide Distribution- US (nationwide) including MA, MN, NY and Puerto Rico; Canada, Mexico, Dubai, Australia, Chile, Colombia, Germany, France, England, Spain, Italy, Norway, Hong Kong, Shanghai, New Zealand, South Africa, Singapore, Japan, Thailand and the Caribbean Islands. |
| Initiated | 2014-08-13 |
| Classified | 2014-09-23 |
| Terminated | 2015-08-06 |
| Recall number | Z-2688-2014 |
| 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-2688-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69137/
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