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.