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 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.
The lack of thermoforming in these devices may cause them to deform, leading to potential performance issues during use. This defect poses a high risk to patients requiring papillotomy procedures.
There have been no reported injuries or incidents associated with this recall. The company is taking proactive measures to ensure patient safety.
Healthcare providers and patients should immediately stop using the device. Follow recall instructions provided by Olympus and contact your healthcare provider for further guidance.
For more details, contact Olympus Corporation of the Americas. Visit their website or call their customer service for instructions.
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