Olympus Corporation of the Americas recalled 650 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform and lose performance due to improper thermoforming. Healthcare providers and patients should 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 product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V411M-3020. Olympus distributed this product Worldwide, including 50 states in the US. The recall affects 650 units.
Devices that did not undergo proper thermoforming could deform, leading to performance issues during procedures. This defect poses a high risk in medical settings.
There are no reported injuries or incidents related to the defective devices at this time. However, the potential for performance failure poses serious risks during clinical use.
Stop using the affected devices immediately. Follow the recall instructions provided by Olympus. Contact Olympus Corporation of the Americas or your healthcare provider for further guidance.
For more information, contact Olympus Corporation of the Americas. Visit their website or call their customer service.
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