Olympus Corporation of the Americas recalled 886 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall follows reports that devices not properly thermoformed could deform and lose performance. Patients and healthcare providers should stop using the device immediately.
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 Disposable Triple Lumen Sphincterotome with model number KD-401Q-0330. It was distributed worldwide, including all 50 US states. The devices are designed for use with Olympus endoscopes and guidewires.
Devices that did not undergo proper thermoforming risk deformation and loss of performance. This could lead to complications during medical procedures.
No specific incidents or injuries have been reported related to this recall. The risk remains high due to the potential for device malfunction.
Stop using the device immediately. Follow the recall instructions provided by Olympus Corporation and contact your healthcare provider for further guidance.
For more information, call Olympus Corporation of the Americas at 1-800-555-1234 or visit their website.
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