Official recall record
CleverCut and FlowCut Sphincterotomes
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-01-23
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
CleverCut and FlowCut sphincterotome devices which did not undergo thermoforming could deform and lose performance. Olympus is removing lots where the devices may not have been manufactured with the thermoforming process. Users are to cease usage and contact customer service to return their affected product.
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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