CleverCut and FlowCut Sphincterotomes
In plain language
This recall involves CleverCut and FlowCut Sphincterotomes sold in Canada. They are being recalled because they may deform and lose performance. Stop using the product and contact the manufacturer for return instructions.
What to do
- Stop using the product immediately.
- Contact the manufacturer for additional information.
- Return the affected product as instructed.
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Affected products
Disposable Triple Lumen Sphincterotome
Model: KD-411Q-0730, KD-V411M-0320, KD-V411M-0330, KD-V411M-0720, KD-V411M-0725, KD-V411M-0730, KD-V431M-0720, KD-V431M-0730
Lot: More than 10 numbers, contact manufacturer.
Sphincterotome
Model: KD-VC411Q-0320, KD-VC411Q-0330, KD-VC411Q-0720, KD-VC412Q-0215, KD-VC431Q-0720, KD-VC433Q-0720, KD-VC433Q-0730
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Performance issues
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: KD-411Q-0730, KD-V411M-0320, KD-V411M-0330, KD-V411M-0720, KD-V411M-0725, KD-V411M-0730, KD-V431M-0720, KD-V431M-0730, KD-VC411Q-0320, KD-VC411Q-0330, KD-VC411Q-0720, KD-VC412Q-0215, KD-VC431Q-0720, KD-VC433Q-0720, KD-VC433Q-0730
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Performance issues
What should consumers do?
Stop using the product immediately. Contact the manufacturer for additional information. Return the affected product as instructed.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Performance issues
When was this product recalled?
This product was recalled on January 23, 2026.
Is the OLYMPUS MEDICAL SYSTEMS CORP. brand affected by this recall?
Yes, OLYMPUS MEDICAL SYSTEMS CORP. products are affected by this recall. This recall involves CleverCut and FlowCut Sphincterotomes sold in Canada. They are being recalled because they may deform and lose performance. Stop using the product and contact the manufacturer for return instructions.