LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used
FDA device recall Z-0962-2025 · posted 2025-01-16 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Potential for distal tip tearing of the Mechanical Lithotriptor V.
- Action taken
- Olympus notified consignees on 12/16/2024, via URGENT: MEDICAL DEVICE REMOVAL letter. Consignees were instructed to examine inventory for affected devices, cease usage of affected devices, and arrange for return of any affected devices. Consignees were also instructed to acknowledge receipt of the letter through Olympus online portal as well as to notify customers if the affected devices were further distributed.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LQC
- Quantity affected
- 989 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-12-16
- Date posted
- 2025-01-16
- Location
- Center Valley, PA
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