Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1059-2023 — FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147

U.S. FDA — Device Enforcement · United States · 2023-01-03 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1059-2023
Date of alert
2023-01-03
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Owens & Minor Distribution, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
20680651471479
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.