Olympus Corporation of the Americas recalled 7,046 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall affects devices that did not undergo proper thermoforming, risking deformation and performance loss. Healthcare providers and patients must stop using these devices 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 recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V411M-1530. It was designed for use with an Olympus endoscope and guidewire for papillotomy. The devices were distributed widely across the U.S. and internationally.
Devices that did not undergo thermoforming could deform, leading to performance issues during medical procedures. This defect poses a high risk to patient safety.
No specific incidents or injuries have been reported related to this recall, but the potential for device malfunction remains a serious concern.
Patients and healthcare providers should immediately stop using the device. Follow recall instructions provided by Olympus Corporation and consult your healthcare provider for further guidance.
For more information, contact Olympus Corporation of the Americas or visit their website. Additional details are available on the FDA's recall page.
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