FDA-PR2026-07-31FOREIGN MATERIAL

OPTIRAY Imaging Bulk Package 350 recalled for particulate matter contamination

GLASSMETALPLASTICNationwide distribution

OPTIRAY contrast agent recalled for particulate matter

Liebel-Flarsheim Company is recalling one lot of OPTIRAY Imaging Bulk Package 350 (a radiographic contrast agent used in hospitals and imaging centers) because it contains particulate matter including plastic, stainless steel, and glass fragments. No adverse events have been reported so far, but contaminated product could cause local irritation, swelling, or in serious cases, blood vessel blockage or clots.

  • If you are a hospital, imaging center, or healthcare facility: immediately stop using the affected product (lot 25ZF3670) and quarantine all inventory.
  • Contact Liebel-Flarsheim or Inmar Inc. at rxrecalls@inmar.com or +1-855-670-3976 to arrange return and replacement.
  • If you received an injection of this product and experience unusual swelling, irritation, or symptoms suggesting blood clots, contact your physician or report the problem to FDA MedWatch.

Product photos

OPTIRAY Imaging Bulk Package (IBP) 500mL in vial, (Ioversol Injection 74% 350 mg iodine/ml), label example
OPTIRAY Imaging Bulk Package (IBP) 500mL in vial, (Ioversol Injection 74% 350 mg iodine/ml), label example
Hazard

FOR IMMEDIATE RELEASE – July 31, 2026 – Raleigh, North Carolina, 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 center

Official notice

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/liebel-flarsheim-company-llc-issues-recall-optiray-imaging-bulk-package-350-500ml-vial-nationwide

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