Olympus Corporation of the Americas recalled 93 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform and lose performance due to a manufacturing flaw. Healthcare providers and patients should stop using the device immediately and follow recall instructions.
Devices which did not undergo thermoforming could deform and lose performance.
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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The Single Use 3-Lumen Sphincterotome V is a medical device used for papillotomy in endoscopic procedures. It facilitates access to the bile duct for treatments using high-frequency current.
If the sphincterotome has not undergone thermoforming, it can deform during use. This deformation may impair its effectiveness and pose serious risks during surgical procedures.
This recall is not part of a broader industry pattern.
Patients may face delays in treatment due to the recall. Healthcare providers must ensure they have safe alternatives available to avoid compromising patient care.
Look for the model number on the device packaging or the device itself, typically near the serial number or on the label.
4-6 weeks for refund processing after returning the device.
Document all correspondence regarding the recall, keep receipts for any returned products, and take photos of the device.
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model Number KD-VC433Q-0730. It was designed for use with Olympus endoscopes for papillotomy. The devices were distributed worldwide, including across multiple U.S. states.
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