Class II — Molnlycke Health Care, Inc
| Recalling firm | MOLNLYCKE HEALTH CARE US LLC |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Sterilization validation failure. |
| Product | Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts' |
| Quantity | 956 units |
| Distribution | Domestic: U.S. Nationwide; Foreign: Austria, Australia, Bangladesh, Canada, Chile, Germany, Denmark, Finland, France, Great Britain, Hong Kong, Hungary, Ireland, India, Italy, Jordan, Korea, Kuwait, Malaysia, Norway, New Zealand, Peru, Saudi Arabia, Sweden Switzerland, Taiwan, Turkey, South Africa, United Arab Emirates. |
| Initiated | 2017-04-24 |
| Classified | 2017-05-18 |
| Recall number | Z-2110-2017 |
| 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 — Molnlycke Health Care, Inc (Z-2110-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77121/
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