Liebel-Flarsheim Company, LLC Issues Recall of OPTIRAY Imaging Bulk Package - 350, 500mL, Vial, Nationwide and Mexico Due to Presence of Particulate Matter

Published: 08/05/2026

Sources:
  • Food and Drug Administration
Relevant To:
  • Ambulatory Surgical Centers,
  • Rural Emergency Hospitals,
  • Urgent Care,
  • Medical Office,
  • Critical Access Hospitals,
  • Hospitals,
  • Ambulatory Care,
  • Rural Health Clinics

Liebel-Flarsheim Company, LLC, is recalling one lot of OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial, (Ioversol Injection 74% 350 mg iodine/ml) for intra-arterial or intra-venous use to the user level (hospitals, imaging centers, healthcare facilities and clinics, and other potential users of the product) due to the presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass.

To date, Liebel-Flarsheim Company, LLC, has not received any…

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