Recall Z-0962-2025— Olympus Corporation of the Americas
Class II · Ongoing
Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2024-12-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Potential for distal tip tearing of the Mechanical Lithotriptor V..
- Recalling firm
- Olympus Corporation of the Americas
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-16
- Firm location
- Center Valley, PA, United States
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.
Reason for recall
Potential for distal tip tearing of the Mechanical Lithotriptor V.
Data sourced from openFDA. This site is unofficial and independent of the FDA.