Single Use Mechanical Lithotriptor V recallZ-0962-2025 · Olympus Corporation of the Americas · initiated Dec 16, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for distal tip tearing of the Mechanical Lithotriptor V.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0962-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 16, 2024
- Posted by the FDA
- Jan 16, 2025
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 989 units
- Product code
- LQC
- Distribution
- US Nationwide distribution.
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.
Code information (models, lots, serial numbers)
UDI-DI: 04953170218422. Model Number: BML-V442QR-30. Lots: 33K-39K, 3XK, 3YK, 3ZK, 41K-44K
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Single Use Mechanical Lithotriptor V BML-V442QR-30Olympus Medical Systems Corp. · Lithotriptor, biliary mechanical1 recall1 death269 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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