Public recall detail

CleverCut and FlowCut Sphincterotomes

2026-01-23

medium
Recall Safety notice
Quick summary

Quick summary: CleverCut and FlowCut Sphincterotomes. Date: 2026-01-23.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: CleverCut and FlowCut Sphincterotomes. Date: 2026-01-23.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandOLYMPUS MEDICAL SYSTEMS CORP.
ProductCleverCut and FlowCut Sphincterotomes
IssueMedical devices - Performance
Recall classType II
IdentificationRA-81525

Affected products

ProductDisposable Triple Lumen Sphincterotome
LotMore than 10 numbers, contact manufacturer.
ModelKD-V411M-0725
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionDisposable Triple Lumen Sphincterotome
ProductDisposable Triple Lumen Sphincterotome
LotMore than 10 numbers, contact manufacturer.
ModelKD-V431M-0720
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionDisposable Triple Lumen Sphincterotome
ProductDisposable Triple Lumen Sphincterotome
LotMore than 10 numbers, contact manufacturer.
ModelKD-411Q-0730
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionDisposable Triple Lumen Sphincterotome
ProductDisposable Triple Lumen Sphincterotome
LotMore than 10 numbers, contact manufacturer.
ModelKD-V431M-0730
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionDisposable Triple Lumen Sphincterotome
ProductDisposable Triple Lumen Sphincterotome
LotMore than 10 numbers, contact manufacturer.
ModelKD-V411M-0320
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionDisposable Triple Lumen Sphincterotome
ProductDisposable Triple Lumen Sphincterotome
LotMore than 10 numbers, contact manufacturer.
ModelKD-V411M-0730
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionDisposable Triple Lumen Sphincterotome
ProductDisposable Triple Lumen Sphincterotome
LotMore than 10 numbers, contact manufacturer.
ModelKD-V411M-0330
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionDisposable Triple Lumen Sphincterotome
ProductDisposable Triple Lumen Sphincterotome
LotMore than 10 numbers, contact manufacturer.
ModelKD-V411M-0720
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionDisposable Triple Lumen Sphincterotome
ProductSphincterotome
LotMore than 10 numbers, contact manufacturer.
ModelKD-VC411Q-0320
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSphincterotome
ProductSphincterotome
LotMore than 10 numbers, contact manufacturer.
ModelKD-VC411Q-0720
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSphincterotome
ProductSphincterotome
LotMore than 10 numbers, contact manufacturer.
ModelKD-VC433Q-0730
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSphincterotome
ProductSphincterotome
LotMore than 10 numbers, contact manufacturer.
ModelKD-VC412Q-0215
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSphincterotome
ProductSphincterotome
LotMore than 10 numbers, contact manufacturer.
ModelKD-VC431Q-0720
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSphincterotome
ProductSphincterotome
LotMore than 10 numbers, contact manufacturer.
ModelKD-VC411Q-0330
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSphincterotome
ProductSphincterotome
LotMore than 10 numbers, contact manufacturer.
ModelKD-VC433Q-0720
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionSphincterotome

Issue

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 you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Gastroenterology and urology Health products - Medical devices - General and plastic surgery
CompaniesOlympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
Recall date2026-01-16
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81525
Background{}
CompaniesOlympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
AudiencesHealthcare
Source updated2026-01-23

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