FDA Device recall Z-0962-2025
LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30 by Olympus, citing potential for distal tip tearing of the Mechanical Lithotriptor V.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0962-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-16 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
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.
Identifiers
| code_info | UDI-DI: 04953170218422. Model Number: BML-V442QR-30. Lots: 33K-39K, 3XK, 3YK, 3ZK, 41K-44K |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0962-2025%22
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