Liebel-Flarsheim Company, LLC Issues Recall of OPTIRAY Imaging Bulk Package - 350, 500mL, Vial, Nationwide and Mexico Due to Presence of Particulate Matter
- Date
- Jul 31, 2026
- Company
- Liebel-Flarsheim Company, LLC
- Brand
- OPTIRAY
- Product
- OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml)
- Reason
- Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass
- Hazard
- Other
- Source
- FDA
How to identify the product
- The affected OPTIRAY 350 IBP 500mL was distributed in the United States and Mexico to distributors and end users (such as hospitals, imaging centers, healthcare facilities and clinics).
- Liebel-Flarsheim Company, LLC, is notifying its distributors and customers by email and is arranging for return and replacement of all recalled products.
- Distributors, hospitals, healthcare facilities and clinics, and other healthcare providers that have the recalled product should immediately stop use and/or further distribution, quarantine all affected product inventory, and follow the instructions in the customer recall notification for arranging return of the affected lot to Liebel-Flarsheim Company, LLC.
Product photos are on the official FDA page.
Facts are taken from the official notice. If anything here differs from it, the official notice is correct.