Liebel-Flarsheim Company LLC FDA Recalls

2 recalls on file across drugs, devices, 1 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial,Class IJul 31, 2026Presence of Particulate Matter: comprising polyethylene and	Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass	Class IDrugs	Jul 31, 2026
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)Class IIMar 11, 2021Failure to comply with the performance standard for fluorosc	Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the display	Class IIDevices	Mar 11, 2021