Olympus Corporation of the Americas recalled 30,489 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall stems from devices that failed to undergo proper thermoforming, risking deformation and performance loss. Healthcare providers and patients must stop using the device 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 Single Use 3-Lumen Sphincterotome V is a medical instrument designed for use during papillotomy procedures in endoscopic surgeries. It allows healthcare providers to use high-frequency current for effective treatment.
The devices may deform if they did not undergo proper thermoforming, which can compromise their performance in critical medical procedures.
This recall is not part of a broader industry pattern.
Patients and healthcare providers need to stop using the recalled devices immediately to avoid potential complications during medical procedures.
Look for the model number and expiration date on the packaging or labeling of the device.
Refund processing may take approximately 4-6 weeks after your request is submitted.
Keep records of your purchase, including receipts and any correspondence related to the recall.
The affected product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V431M-0720. It has been distributed globally, including in 50 U.S. states. The recall includes 11,779 units in the U.S. and 18,710 units internationally.
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