Z-0962-2025Class II

LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical...

Name: Z-0962-2025 LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical...
Creator: Olympus Corporation of the Americas
Published: 2024-12-16
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-12-16 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing... on 2024-12-16. FDA classified it as Class II and gives the reason as "Potential for distal tip tearing of the Mechanical Lithotriptor V". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0962-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-16
Posted: 2025-01-16
Recalling firm: OLYMPUS Corporation of the Americas
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.
Product code: LQC Lithotriptor, Biliary Mechanical
Reason for recall: Potential for distal tip tearing of the Mechanical Lithotriptor V.
FDA root cause: Under Investigation by firm
Action: Olympus notified consignees on 12/16/2024, via URGENT: MEDICAL DEVICE REMOVAL letter. Consignees were instructed to examine inventory for affected devices, cease usage of affected devices, and arrange for return of any affected devices. Consignees were also instructed to acknowledge receipt of the letter through Olympus online portal as well as to notify customers if the affected devices were further distributed.
Quantity in commerce: 989 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 04953170218422. Model Number: BML-V442QR-30. Lots: 33K-39K, 3XK, 3YK, 3ZK, 41K-44K

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0962-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0962-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-16

Product code LQC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)