Olympus Corporation of the Americas recalled 1,980 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall affects devices that did not undergo thermoforming, risking deformation and loss of performance. Healthcare providers must stop using these devices 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, Model/Catalog Number KD-401Q-0725. It was distributed worldwide, including nationwide in the US across multiple states. These devices are typically used with an Olympus endoscope and guidewire for papillotomy.
The sphincterotome may deform and lose performance due to a failure in the thermoforming process. This defect poses a high risk to patient safety during medical procedures.
No specific incidents or injuries have been reported related to this recall. The potential for performance loss could lead to significant complications during medical use.
Patients and healthcare providers should stop using the sphincterotome immediately. Contact Olympus Corporation of the Americas for further instructions and follow the recall notifications sent to affected parties.
For further details, contact Olympus Corporation of the Americas. Visit their website or call customer service for assistance.
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