Olympus Corporation of the Americas recalled 12,641 Single Use Sphincterotome V devices on January 7, 2026. The devices may deform due to a manufacturing defect, posing a high risk of performance failure. Healthcare providers and patients must stop using these instruments 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 affected model is the Single Use Sphincterotome V, Model/Catalog Number: KD-VC431Q-0720. These devices were distributed worldwide, including 8,789 units in the U.S. They are designed for use with Olympus endoscopes and guidewires for papillotomy, using high-frequency current.
The recalled devices did not undergo proper thermoforming during manufacturing, which could lead to deformation. This defect can result in the loss of performance, which may compromise patient safety.
No specific incidents or injuries have been reported to date. However, the potential risk associated with device deformation poses a high concern for healthcare providers and patients.
Patients and healthcare providers should cease using the recalled devices immediately. Follow the recall instructions provided by Olympus Corporation of the Americas or consult your healthcare provider for further guidance.
To report usage or obtain more information, contact Olympus Corporation of the Americas. For further assistance, visit the official FDA website.
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