Liebel-Flarsheim Company, LLC Issues Recall of OPTIRAY Imaging Bulk Package - 350, 500mL, Vial, Nationwide and Mexico Due to Presence of Particulate Matter
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
Dental practices that administer contrast-enhanced CBCT or 3-D imaging using OPTIRAY 350 bulk vials now face an immediate recall for particulate contamination that could reach patients during intra-arterial/intra-venous injections.
Key points
- Lot affected: OPTIRAY Imaging Bulk Package (Ioversol 350 mg I/mL) 500 mL vials; recall initiated 31 July 2026 at the user level.
- Risk: particulate matter in the vial can cause micro-emboli or adverse injection reactions in patients undergoing contrast CBCT, angiography, or sialography.
- Action required: dental imaging centers and oral-surgery practices should quarantine stock, notify staff, and contact Liebel-Flarsheim for return/replacement instructions.
- Geographic scope: nationwide U.S. and Mexico distribution; hospitals, outpatient imaging centers, and any dental facility using bulk contrast are included.
Who should care
Read the original on FDA Recalls
Full reporting and any paywall content live on fda.gov. We summarize and score; we do not republish.
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