Saint Louis, MO, United States
LIEBEL-FLARSHEIM COMPANY LLC recalls
3 recalls recorded since 2018, most recently on 31 July 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)1
Ongoing Class I Drugs
- Recall started
- 31 July 2026
- Reason
- Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
- Distribution
- Distributed Nationwide in the US and Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0773-2026
- 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 i
Terminated Class II Medical devices
- Recall started
- 11 March 2021
- Terminated
- 18 September 2024
- Reason
- Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ¿ 35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose.
- Distribution
- US Nationwide Distribution and in the country of Canada
- Initiated
- FDA Mandated
- Recall number
- Z-1992-2021
- HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Terminated Class II Medical devices
- Recall started
- 27 February 2017
- Terminated
- 16 August 2023
- Reason
- Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings.
- Distribution
- US Distribution to: AL, AZ, CA, CT, CO, FL GA, HI, IA, IL, ID, KS, KY, MD, MI, Michigan, MN, NC, NH, NV, NY, OK, OH, PA, SC, TN, TX, VA, WA, WI, and WV,
- Initiated
- FDA Mandated
- Recall numbers
- Z-2834-2018, Z-2833-2018
- Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological a
- Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urologica
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.