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The official notice did not include a photo. Check the product details and identifiers below.
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Clevercut and flowcut sphincterotomes
Official notice
23 Jan 2026
An official Health Canada notice concerns Clevercut and flowcut sphincterotomes. 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. Published 2026-01-23.
What to do now
Contact the manufacturer if you require additional information.
Recall number
81525
Official notice
2026-01-23
The hazard
The hazard
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.
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Olympus Medical.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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