Olympus LithoCrushV Mechanical Lithotriptor Recalled for Distal Tip Tearing Risk
Olympus Corporation recalls the LithoCrushV Single Use Mechanical Lithotriptor due to potential distal tip tearing during endoscopic procedures. The FDA Class II recall affects 989 units distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a medical device with potential for mechanical failure. No illnesses or injuries have been reported, and the hazard is theoretical rather than realized. Per the severity rubric, risk-of-harm products where injury has not yet been reported score at a maximum of 3 (High).
Plain-English summary
Olympus Corporation of the Americas is recalling the LithoCrushV Single Use Mechanical Lithotriptor V (Model BML-V442QR-30), a medical device used in endoscopic procedures to crush gallstones in the bile duct.
The device is being recalled because of the potential for the distal tip to tear during use.
This recall affects 989 units distributed nationwide in the United States. The affected product lots are: 33K-39K, 3XK, 3YK, 3ZK, and 41K-44K. Patients and healthcare providers who have this device should contact Olympus Corporation of the Americas for instructions on product return or disposal.
The recalled product
- 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.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 989
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 04953170218422. Model Number: BML-V442QR-30. Lots: 33K-39K
- 3XK
- 3YK
- 3ZK
- 41K-44K
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Olympus Corporation of the Americas
See all →- ModerateOlympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
- ModerateOlympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
- SevereOlympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
Similar recalls
- HighOlympus Single Use Distal Cover for Endoscope Recalled Due to Detachment Risk
FDA (Devices) · 2023-05-31
- HighOlympus Tracheal Intubation Fiberscope Recalled Due to Lodging Risk
FDA (Devices) · 2023-09-06
- HighHemostatic Clip Device Recalled Due to Deployment Failures
FDA (Devices) · 2023-06-28
- HighOlympus resection sheath recalled after reports of ceramic tip breaking
FDA (Devices) · 2026-03-04
- HighOlympus Single-Use Endoscopic Clip Fixing Device Recalled for Deployment Failure
FDA (Devices) · 2023-04-26
- SevereOlympus Electrosurgical Knives Recalled Due to Breakage During Use
FDA (Devices) · 2024-09-18