Recall archive / FDA device enforcement
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code... — FDA record Z-1059-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 3, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
- Reason
- 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.
- Classification
- Class III
- Recalling firm
- Owens & Minor Distribution, Inc.
- Quantity
- 73 cases
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1059-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI 20680651471479 Lot AM2222041 Expiration Date 2027-08-10 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to IL, NC, NY, OH, and PA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 15, 2023
- Recall initiation date
- Jan 3, 2023
- Center classification date
- Feb 3, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.