Olympus Corporation of the Americas recalled 2,344 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform due to improper thermoforming, leading to performance issues. This recall affects units distributed worldwide, including all U.S. states.
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-V411M-3030. The device is designed for use with an Olympus endoscope and guidewire for papillotomy using high-frequency current. It was distributed worldwide, including various states across the U.S.
Devices that did not undergo proper thermoforming may deform and lose performance. This defect can impact the safety and effectiveness of the device during medical procedures.
There are no reported injuries or incidents associated with this recall. The risk level is classified as high due to the potential for device malfunction.
Stop using the device immediately. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions and to follow the recall process.
For more information, contact Olympus Corporation of the Americas at their official website or through the recall notification letter.
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