Olympus Corporation of the Americas: Device Recall

Recall #Z-0962-2025 · 12/16/2024

Class II: Risk

Recall Details

Recall Number
Z-0962-2025
Classification
Class II
Product Type
Device
Recalling Firm
Olympus Corporation of the Americas
Status
Ongoing
Date Initiated
12/16/2024
Location
Center Valley, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
989 units

Reason for Recall

Potential for distal tip tearing of the Mechanical Lithotriptor V.

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.

Distribution Pattern

US Nationwide distribution.

Other Recalls by Olympus Corporation of the Americas

View all recalls by Olympus Corporation of the Americas →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.