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 | Ongoing |
| Reason | Sterility seal integrity failures on the Renasys Sterile Transparent Film |
| Product | RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wounds types include chronic, acute, traumatic, Sub-Acute and dehisced wounds, ulcers, (such as pressure and diabetic), partial thickness burns, flaps and grafts. |
| Quantity | 45,455 devices (in the USA) |
| Distribution | Nationwide Distribution to AK, AL, AR, AZ, CA, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, WA, WI, Hawaii, and Puerto Rico Argentina, Australia, Bermuda, Brazil, Brunai, Canada, Curacao, Germany, Great Britain, Hong Kong, Ireland, Jordan, Malaysia, New Zeland, Peru, Saudi Arabia, Serbia, Singapore, South Africa, SriLanka, Tunisia, Turkey… |
| Initiated | 2016-07-21 |
| Classified | 2016-09-20 |
| Recall number | Z-2848-2016 |
| 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-2848-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74885/
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