LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mech...
FDA Recall #Z-0962-2025 — Class II — December 16, 2024
Product Description
LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
Reason for Recall
Potential for distal tip tearing of the Mechanical Lithotriptor V.
Recalling Firm
Olympus Corporation of the Americas — Center Valley, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
989 units
Distribution
US Nationwide distribution.
Code Information
UDI-DI: 04953170218422. Model Number: BML-V442QR-30. Lots: 33K-39K, 3XK, 3YK, 3ZK, 41K-44K
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated