Brennen Skin Graft Mesher — Class II medical device recall Z-2110-2017
Ongoing recall by Molnlycke Health Care, Inc, reported 2017-05-24, distributed nationwide. Sterilization validation failure.
| Recall number | Z-2110-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Molnlycke Health Care, Inc, Norcross, GA, United States |
| Recall initiated | 2017-04-24 |
| Classified | 2017-05-18 |
| Reported by FDA | 2017-05-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, CA, CH, CL, DE, DK, FI, FR, GB, HK, HU, IE, IN, IT, JO, KR, KW, MY, NO, NZ, PE, SA, SE, TR, TW, ZA |
| Quantity | 956 units |
Product
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
Reason for recall
Sterilization validation failure.
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-2110-2017. 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.