Olympus LithoCrushV Single Use Mechanical Lithotriptor V Recall: Distal Tip Tearing Risk
Olympus recalls LithoCrushV Single Use Mechanical Lithotriptor V model BML-V442QR-30 due to potential distal tip tearing. Affected units sold in lots 33K-44K. Contact Olympus for remedy.
Recall notice
Potential for distal tip tearing of the Mechanical Lithotriptor V.
Contact the company
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. Read more at govinfonow.com/recall/53293-olympus-lithocrushv-single-use-mechanical-lithotriptor-v-recall-distal-tip.
Source Summary by GovInfoNow · govinfonow.com/recall/53293-olympus-lithocrushv-single-use-mechanical-lithotriptor-v-recall-distal-tip · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0962-2025
Cite this page
“Olympus LithoCrushV Single Use Mechanical Lithotriptor V Recall: Distal Tip Tearing Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53293-olympus-lithocrushv-single-use-mechanical-lithotriptor-v-recall-distal-tip. Based on FDA recall #Z-0962-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0962-2025%22&limit=1).
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
What to do — step by step
Check Device Model
Look for model number BML-V442QR-30 on the LithoCrushV device.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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.