FDAClass IIJanuary 22, 2025

LithoCrushV Single Use Mechanical Lithotriptor V recall

LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for…

Why was LithoCrushV Single Use Mechanical Lithotriptor V recalled?

Potential for distal tip tearing of the Mechanical Lithotriptor V.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for…
Recalling firm
Olympus Corporation of the Americas
Quantity
989 units
Distribution
US Nationwide distribution.
Recall date
January 22, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls