Notice names this product. Liebel-Flarsheim Company’s Optiray Imaging Bulk Package-350 is named in FDA Class I recall D-0773-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. Identifying details: Lot # 25ZF3670, Exp Date: May 31, 2027.. Units affected: 3,486 500mL-vials. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Company / brand: Liebel-Flarsheim Company
Affected product: Optiray Imaging Bulk Package-350
Official ID D-0773-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.