Home / Recalls / Olympus Corporation of the Americas / Z-0962-2025

Z-0962-2025 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
January 22, 2025
Initiation Date
December 16, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
989 units

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.

Distribution Pattern

US Nationwide distribution.

Code Information

UDI-DI: 04953170218422. Model Number: BML-V442QR-30. Lots: 33K-39K, 3XK, 3YK, 3ZK, 41K-44K

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