Olympus Corporation of the Americas recalled 7,689 Disposable Triple Lumen Sphincterotomes on January 7, 2026. The devices may deform due to inadequate thermoforming, risking performance failure during medical procedures. Healthcare providers must stop using these devices immediately and follow 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 recalled product is the Disposable Triple Lumen Sphincterotome, Model/Catalog Number KD-431Q-0720. It was distributed globally, including 7,501 units in the U.S. The devices were sold through various healthcare providers.
The sphincterotome may deform if it did not undergo proper thermoforming. This malfunction can lead to serious performance issues during medical procedures, posing risks to patient safety.
No specific injuries have been reported due to this defect. However, the potential for serious complications exists if the device fails during use.
Patients and healthcare providers should stop using the affected device immediately. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions on the recall.
For more information, contact Olympus Corporation of the Americas at 1-800-223-2500 or visit their website.
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