Class II

Medical Device Recall: 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.

Olympus Corporation of the Americas · December 16, 2024

Reason for Recall

Potential for distal tip tearing of the Mechanical Lithotriptor V.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

989 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0962-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Olympus Corporation of the Americas Medical Device Recall: 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. | SafeCheck