Olympus Corporation of the Americas recalled 65,117 Single Use 3-Lumen Sphincterotome V devices on January 7, 2026. Improper thermoforming may cause the devices to deform and lose performance. Users should stop using the device immediately and follow the manufacturer’s 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 recalled product is the Single Use 3-Lumen Sphincterotome V, model number KD-V411M-0720. It was distributed worldwide, including in 9,707 units in the U.S. The devices were sold at multiple retailers and have a classification of Class II.
The sphincterotome may deform due to insufficient thermoforming, leading to loss of performance during use. This high-risk issue can potentially affect the efficacy of medical procedures performed with the device.
As of now, there are no reported injuries or deaths linked to this recall. The potential for device malfunction raises serious concerns for patient safety.
Patients and healthcare providers should stop using the device immediately. They should follow the recall instructions provided in the notification letter from Olympus Corporation.
For further instructions, contact Olympus Corporation of the Americas. Visit their website or call their customer service for assistance with the recall.
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