Olympus Corporation of the Americas recalled 999 units of the Disposable Triple Lumen Sphincterotome on January 7, 2026. Devices may deform and lose performance due to improper thermoforming. Patients and healthcare providers should stop using the product 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 Disposable Triple Lumen Sphincterotome is a medical instrument used for papillotomy, which is a procedure to remove stones from the bile duct. Healthcare providers use this device in conjunction with endoscopes to ensure precise operation during medical procedures.
If the sphincterotome does not undergo proper thermoforming, it can deform, leading to reduced performance. This defect could compromise patient safety during medical use.
This recall is not part of a broader industry pattern.
Patients relying on this device for critical medical procedures face potential risks if the device is used. The urgency of the situation necessitates immediate action from healthcare providers to ensure patient safety.
The model number and relevant identifiers can usually be found on the packaging or directly on the device itself.
Expect refund processing to take 4-6 weeks once the return is initiated.
Keep records of any communication with Olympus Corporation and your healthcare provider regarding the recall.
The recalled model is the KD-401Q-0320, which is designed for use with Olympus endoscopes and guidewires for papillotomy. The recall affects 999 units distributed worldwide, including across multiple U.S. states.
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