FDA Device recall Z-1059-2023
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
- FDA Device
- Class III
- ongoing
- Published 2023-02-15
On 2023-02-15 the FDA classified a Class III recall of FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147 by Owens And Minor Distribution, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1059-2023 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-01-03 |
| Published | 2023-02-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Owens And Minor Distribution |
| Distribution | IL, NC, NY, OH, PA |
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.
Identifiers
| code_info | UDI-DI 20680651471479 Lot AM2222041 Expiration Date 2027-08-10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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FDA Device · Class II · 2016-02-10 · Owens And Minor Distribution
All Owens And Minor Distribution recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1059-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.