Official recall record
Single Use Mechanical Lithotriptor V
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-12-31
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Olympus has identified an increase in complaints for BML-V442QR-30. The complaint data analysis found that distal tip tearing of the Mechanical Lithotriptor V had increased beginning with the production of lot 33k. Olympus has identified 296 complaints for the BML-V442QR-30 globally between June 1, 2021, through July 31, 2024. There were 169 reportable malfunctions, and there was one report of a serious injury in relation to this issue. Recall start date: December 18, 2024
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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