FDA recall Z-0962-2025

Olympus Corporation of the Americas · Class II · device

Product

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.

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2024-12-16
Report date: 2025-01-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0962-2025