HIGH

Olympus Sphincterotome Recalled Due to Deformation Risk

Olympus Corporation recalled 1,474 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform and lose performance due to improper thermoforming. Healthcare providers and patients must stop using these instruments immediately.

Quick Facts at a Glance

Recall Date
January 7, 2026
Hazard Level
HIGH
Brand
Olympus Corporation of the Americas
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Devices which did not undergo thermoforming could deform and lose performance.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-VC411Q-0725. It was distributed worldwide, including all states in the U.S. The devices were designed for use with Olympus endoscopes for papillotomy.

The Hazard

The devices may deform due to improper thermoforming, which can lead to compromised performance during medical procedures. This defect poses a high risk to patient safety.

Reported Incidents

There have been no reported injuries or incidents associated with the use of these devices as of the recall date.

What to Do

Stop using the device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions.

Contact Information

For more information, contact Olympus Corporation of the Americas at their official website or by calling their customer service.

Key Facts

  • Recall date: January 7, 2026
  • Quantity recalled: 1,474 units
  • Hazard: Devices may deform and lose performance
  • Immediate action required: Stop using the device

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Model/Catalog Number: KD-VC411Q-0725
Material REF: N5424710
UDI-DI: N/A
All Lots with a valid expiration date
Affected States
ALL
Report Date
February 11, 2026
Recall Status
ACTIVE

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