Liebel-Flarsheim Company, LLC has initiated a nationwide and Mexico recall of one lot of its OPTIRAY Imaging Bulk Package (IBP) 350, 500mL vials, used for intra-arterial or intra-venous imaging. The recall, announced on July 31, 2026, is due to the discovery of particulate matter, including polyethylene, other plastics, stainless steel, and glass, within the product.
The affected product is Ioversol Injection 74% 350 mg iodine/ml. This recall extends to the user level, encompassing hospitals, imaging centers, healthcare facilities, and clinics. The administration of injectable products containing such particulates carries risks, potentially causing local irritation or swelling.
More severe consequences for compromised patients could include life-threatening events like blood vessel blockage and blood clots. Liebel-Flarsheim Company, LLC, based in Raleigh, North Carolina, has confirmed that no adverse events related to this specific issue have been reported to date.