FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT… — Class III medical device recall Z-1059-2023
Ongoing recall by Owens & Minor Distribution, Inc., reported 2023-02-15, distributed in IL, NC, NY, OH, PA. Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispens
| Recall number | Z-1059-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Owens & Minor Distribution, Inc., Mechanicsville, VA, United States |
| Recall initiated | 2023-01-03 |
| Classified | 2023-02-03 |
| Reported by FDA | 2023-02-15 |
| Distributed | IL, NC, NY, OH, PA |
| Quantity | 73 cases |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 20680651471479 |
| Lot numbers | AM2222041 |
| Expiration dates | 2027-08-10 |
Product
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Reason for recall
Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.
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-1059-2023. 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.