Olympus LithoCrushV Single Use Mechanical Lithotriptor V Recall: Distal Tip Tearing Risk

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Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling its LithoCrushV Single Use Mechanical Lithotriptor V model BML-V442QR-30 because the distal tip may tear. This could lead to complications during bile duct procedures. Affected units were sold in specific lots between 33K-44K.

Why it’s dangerous

The distal tip of the Lithotriptor V may tear during use, potentially causing complications in bile duct procedures. This device is used with an endoscope to crush stones inside the bile duct.

Who’s affected

Patients using this device for bile duct procedures are affected. Medical professionals who use the device for stone removal are most at risk.

How to tell if you have this one

Check for model number BML-V442QR-30 on the device. Affected units were sold in lots 33K-39K, 3XK, 3YK, 3ZK, and 41K-44K.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for model number BML-V442QR-30 on the LithoCrushV device.

✎ GovInfoNow

Questions people ask

What is the hazard with this device?

The distal tip of the Lithotriptor V may tear during use, potentially causing complications in bile duct procedures.

How can I tell if I have the recalled device?

Check for model number BML-V442QR-30 and lots 33K-39K, 3XK, 3YK, 3ZK, or 41K-44K.

What should I do if I have the recalled device?

The recall record does not specify a remedy, so contact Olympus directly for instructions.

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Contact Olympus

We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0962-2025 — Olympus Olympus

Hello,

I own a Olympus that is covered by recall Z-0962-2025 from Olympus.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0962-2025 (December 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0962-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Olympus Corporation of the Americas recalls LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V

Recall notice