LithoCrushV Single Use Mechanical Lithotriptor V — Class II medical device recall Z-0962-2025
Ongoing recall by Olympus Corporation of the Americas, reported 2025-01-22, distributed nationwide. Potential for distal tip tearing of the Mechanical Lithotriptor V.
| Recall number | Z-0962-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2024-12-16 |
| Classified | 2025-01-16 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Quantity | 989 units |
| UPC / GTIN / UDI-DI | 04953170218422 |
| Lot numbers | 33K-39K, 3XK, 3YK, 3ZK, 41K-44K |
| Model numbers | 33K-39K, 3XK, 3YK, 3ZK, 41K-44K, BML-V442QR-30 |
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 for recall
Potential for distal tip tearing of the Mechanical Lithotriptor V.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0962-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.