Liebel-Flarsheim recalls Optiray Imaging Bulk Package-350 (Ioversol 74%) due to potential particulate matter in the injection solution. This could cause blockages or reactions if injected. Affected units have NDC 0019-1333-65 and lot # 25ZF3670.
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
✎ GovInfoNow plain-language explainer
Liebel-Flarsheim is recalling Optiray Imaging Bulk Package-350 (Ioversol 74%) injections because they may contain plastic, metal, and glass particles. This could cause blockages or reactions if injected into the body. The recall affects medical facilities using this product for imaging procedures. Read more at govinfonow.com/recall/454404-liebel-flarsheim-optiray-imaging-bulk-package-350-recall-particulate-matter.
“Liebel-Flarsheim Optiray Imaging Bulk Package-350 Recall: Particulate Matter Hazard.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/454404-liebel-flarsheim-optiray-imaging-bulk-package-350-recall-particulate-matter. Based on FDA recall #D-0773-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0773-2026%22&limit=1).
The FDA announced on July 31, 2026, that Liebel-Flarsheim Company LLC is recalling Optiray Imaging Bulk Package-350 due to the presence of particulate matter. The Class I recall affects 3,486 multiple-dose vials distributed nationwide.
The recall is due to the presence of particulate matter comprising polyethylene, other plastic materials, stainless steel, and glass. The FDA classified this as a Class I hazard.
Context
GovInfoNow's records show Liebel-Flarsheim Company LLC has one other recall on record since March 11, 2021, involving the HydraVision Digital Imaging System. Other recent recalls of similar products include B. Braun Medical Lactated Ringer's Injection Recall (August 12, 2026), GE Healthcare Omnipaque 300 mg/mL Injection Recall (March 24, 2026), and GE Healthcare Omnipaque Injection Recall (March 24, 2026).
How to tell if you have this one
Check for the product name 'Optiray Imaging Bulk Package-350' with NDC 0019-1333-65 and lot number 25ZF3670. The product is a 500 mL multiple-dose vial for medical imaging procedures.
Brand
Liebel-Flarsheim
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the NDC code 0019-1333-65 and lot number 25ZF3670 on the vial label.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distributed Nationwide in the US and Mexico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 19 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The recall indicates potential particulate matter, but the product is still safe for use if the particulate matter is not present. The manufacturer recommends checking the lot number and NDC code.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0773-2026 (July 31, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0773-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.