Olympus Corporation of the Americas recalled 1,490 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The devices may deform due to improper thermoforming, risking performance failure. Healthcare providers should immediately stop using these devices 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 recalled product is the Disposable Triple Lumen Sphincterotome, Model/Catalog Number: KD-401Q-0730. It is designed for use with an Olympus endoscope and guidewire for papillotomy using high-frequency current. The affected units were distributed worldwide, including across multiple U.S. states.
The devices may deform and lose performance if they did not undergo proper thermoforming. This defect poses a high risk to patients undergoing procedures that rely on the integrity of the device.
There have been no reported injuries or incidents at this time, but the potential for performance failure raises significant concerns.
Patients and healthcare providers should stop using the recalled devices immediately. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions and follow the recall instructions provided.
Contact Olympus Corporation of the Americas for more information at [insert phone number] or visit their website at [insert website link].
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