Z-0962-2025 Class II Ongoing
FDA device recall Z-0962-2025 was initiated by Olympus Corporation of the Americas on December 16, 2024 and is designated Class II. Reason for recall: Potential for distal tip tearing of the Mechanical Lithotriptor V. The recall status is ongoing. Affected quantity: 989 units.
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