Olympus Corporation of the Americas recalled 3,954 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall occurred due to devices that may not have undergone proper thermoforming, risking deformation and loss of performance. Healthcare providers and patients should stop using the devices immediately and follow the 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 affected product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V411M-1520. It was distributed worldwide, including across all U.S. states. The product is used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
The recalled devices may deform due to improper thermoforming, leading to a significant loss of performance during medical procedures. This poses a high risk to patient safety.
As of now, there are no reported incidents of injury or death associated with the use of the affected devices.
Patients and healthcare providers should stop using the device immediately. They must follow the recall instructions provided by the manufacturer and contact Olympus Corporation of the Americas for further guidance.
For questions or to report concerns, contact Olympus Corporation of the Americas. Reach out via their customer service line or visit their website for additional information.
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