Olympus Corporation of the Americas recalled 1,504 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform and lose performance due to a manufacturing issue. Healthcare providers and patients should stop using the 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 Single Use 3-Lumen Sphincterotome V, Model/Catalog Number: KD-VC433Q-0720. The recall affects 350 units distributed in the U.S. and 1,154 units distributed internationally.
The devices may deform and lose performance if they did not undergo thermoforming. This defect poses a significant risk during medical procedures.
There are no reports of injuries or incidents related to the recalled devices at this time. However, the potential for performance failure poses a high risk in clinical settings.
Stop using the affected devices immediately. Follow the recall instructions provided by the manufacturer and contact your healthcare provider for further guidance.
For more information, contact Olympus Corporation of the Americas. Visit their website or call their customer service for assistance.
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