Olympus Corporation of the Americas: Medical Device Recall in 2025 - (Recall #: Z-0962-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 16, 2024

Date Posted: January 22, 2025

Recall Number: Z-0962-2025

Event ID: 95907

Reason for Recall:

Potential for distal tip tearing of the Mechanical Lithotriptor V.

Status: Ongoing

Product Quantity: 989 units

Code Information:

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

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated