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 | Terminated |
| Reason | Products may not meet specifications due to possible presence of metal shavings. |
| Product | 7x10" Small Utility Positioner with Cover |
| Quantity | 960 units total |
| Distribution | Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI. |
| Initiated | 2017-07-26 |
| Classified | 2018-01-26 |
| Terminated | 2021-04-06 |
| Recall number | Z-0416-2018 |
| 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-0416-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78058/
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