medical Class II Updated 2025-01-22

Olympus Corporation of the Americas recalls LithoCrushV Single Use Mechanical Lithotriptor V. Model Numb

Recalled 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.


Hazard / Issue

Potential for distal tip tearing of the Mechanical Lithotriptor V.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 04953170218422. Model Number: BML-V442QR-30. Lots: 33K-39K, 3XK, 3YK, 3ZK, 41K-44K
View official government recall

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