9x15" Medium Utility Positioner with Cover — Class II medical device recall Z-0417-2018
Terminated recall by Molnlycke Health Care, Inc, reported 2018-02-07, distributed in AR, CT, FL, GA, IA, IL, LA, MA…. Products may not meet specifications due to possible presence of metal shavings.
| Recall number | Z-0417-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Molnlycke Health Care, Inc, Norcross, GA, United States |
| Recall initiated | 2017-07-26 |
| Classified | 2018-01-26 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2021-04-06 |
| Distributed | AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI |
| Quantity | 204 units |
| Reason classes | foreign material |
Product
9x15" Medium Utility Positioner with Cover
Reason for recall
Products may not meet specifications due to possible presence of metal shavings.
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-0417-2018. 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.