Liebel-Flarsheim Company LLC
Liebel-Flarsheim Company LLC appears in FDA public data with 4 recalls — including 1 Class I (most serious) —, 2 510(k) clearances, 12 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0773-2026, Class I) was initiated on July 31, 2026. Its most recent 510(k) clearance was granted on November 18, 2020.
Summary
- Total Recalls
- 4 (1 Class I)
- 510(k) Clearances
- 2
- Inspections
- 12
- Compliance Actions
- 1
Known Names
liebel-flarsheim company, liebel-flarsheim
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0773-2026 | Class I | Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL | July 31, 2026 |
| Z-1992-2021 | Class II | HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW) | March 11, 2021 |
| Z-2834-2018 | Class II | Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitat | February 27, 2017 |
| Z-2833-2018 | Class II | Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facili | February 27, 2017 |