Drug recall
LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical…
FDA recall event 95907 · Class II · Olympus Corporation of the Americas
Key facts
| Event ID | 95907 |
|---|---|
| Recall numbers | Z-0962-2025 |
| Recalling firm | Olympus Corporation of the Americas |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for distal tip tearing of the Mechanical Lithotriptor V. |
| Initiation date | Dec 16, 2024 |
| Report date | Jan 22, 2025 |
| City | Center Valley |
| State | PA |
| Country | United States |
| FEI number | 2429304 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: