Olympus Corporation of the Americas recalled 1,025 units of its Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform due to inadequate thermoforming, posing a high hazard level. Patients and healthcare providers must stop using the devices immediately and follow recall instructions.
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 with an Olympus endoscope for papillotomy procedures. These devices are critical for minimally invasive surgeries.
The lack of proper thermoforming in the manufacturing process can lead to deformation of the device, reducing its effectiveness and safety during use in medical procedures.
This recall is not part of a broader industry pattern.
The recall may cause inconvenience for healthcare providers who rely on this device for procedures, potentially leading to delays in patient care.
The model number and catalog number can typically be found on the device packaging or the device itself.
Expect a refund or replacement processing timeline of approximately 4-6 weeks.
Keep a record of your purchase, any emails or letters from Olympus, and photographs of the device.
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number: KD-V411M-3025. The product was distributed worldwide, including all U.S. states, with a total quantity of 1,025 units.
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