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Clevercut and flowcut sphincterotomes

Official notice

23 Jan 2026

Last checked

23 Jan 2026

Medium riskHealth Canada
Watch Olympus Medical

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

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

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Skus

KD-V411M-0725, KD-V431M-0720, KD-411Q-0730, KD-V431M-0730, KD-V411M-0320, KD-V411M-0730, KD-V411M-0330, KD-V411M-0720, KD-VC411Q-0320, KD-VC411Q-0720, KD-VC433Q-0730, KD-VC412Q-0215, KD-VC431Q-0720, KD-VC411Q-0330, KD-VC433Q-0720

Other

RA RA-81525

Model Numbers

KD-V411M-0725, KD-V431M-0720, KD-411Q-0730, KD-V431M-0730, KD-V411M-0320, KD-V411M-0730, KD-V411M-0330, KD-V411M-0720, KD-VC411Q-0320, KD-VC411Q-0720, KD-VC433Q-0730, KD-VC412Q-0215, KD-VC431Q-0720, KD-VC411Q-0330, KD-VC433Q-0720

Recall Numbers

81525

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Affected products

Product 1

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - KD-V411M-0725

Product 2

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - KD-V431M-0720

Product 3

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - KD-411Q-0730

Product 4

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - KD-V431M-0730

Product 5

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - KD-V411M-0320

Product 6

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - KD-V411M-0730

Product 7

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - KD-V411M-0330

Product 8

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - KD-V411M-0720

Product 9

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - KD-VC411Q-0320

Product 10

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - KD-VC411Q-0720

Product 11

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - KD-VC433Q-0730

Product 12

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - KD-VC412Q-0215

Product 13

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - KD-VC431Q-0720

Product 14

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - KD-VC411Q-0330

Product 15

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - KD-VC433Q-0720

Risk / 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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Olympus Medical

Manufacturer

Not provided

Phone

Not provided

Brand: Olympus Medical.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

81525

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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