RENASYS Sterile Transparent Film and all the RENASYS Dressing kits… — Class II medical device recall Z-2848-2016
Ongoing recall by Smith & Nephew, Inc., reported 2016-09-28, distributed nationwide. Sterility seal integrity failures on the Renasys Sterile Transparent Film
| Recall number | Z-2848-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Saint Petersburg, FL, United States |
| Recall initiated | 2016-07-21 |
| Classified | 2016-09-20 |
| Reported by FDA | 2016-09-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BM, BR, CA, CW, DE, GB, HK, IE, JO, MY, PE, RS, SA, SG, TN, TR, ZA |
| Quantity | 45,455 devices |
| Reason classes | sterility, packaging |
| Lot numbers | 00815K, 00815N, 01215G, 014091306, 01415G, 015030904, 015050996, 015060209, 015061065, 02014P, 02015E, 02214J, 04916J, 05014D, 05014F, 05014M, 05316P, 05516D, 05715H, 06914E, 07715M, 08915D, 08915E, 09014K, 09214H, 09914K, 1015G, 11214JV, 11414AV, 11414BV, 13414K, 14014L, 15414T, 15514G, 16014CV, 16014F, 16914G, 16914H, 16914J, 17014K and 332 more |
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.
Reason for recall
Sterility seal integrity failures on the Renasys Sterile Transparent Film
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-2848-2016. 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.