Olympus Corporation of the Americas recalls LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V use…
- Recall date
- December 16, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0962-2025
- FDA classification
- Class II
- Brand / firm
- Olympus Corporation of the Americas
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
Potential for distal tip tearing of the Mechanical Lithotriptor V.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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