Olympus Corporation of the Americas recalled 1,072 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall addresses devices that did not undergo proper thermoforming, risking performance failure. Healthcare providers and patients should stop using the 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 Disposable Triple Lumen Sphincterotome is a medical device used in endoscopic procedures for papillotomy using high-frequency current. Healthcare providers utilize this device to facilitate access to the bile duct during surgeries.
The devices at risk did not undergo adequate thermoforming, which can lead to deformation during use. This deformation can compromise the effectiveness of the instrument during critical medical procedures.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must stop using the affected devices to avoid complications in medical procedures, highlighting the need for prompt action.
Model numbers and lot numbers can usually be found on the packaging or directly on the device itself.
Expect a refund or replacement processing time of approximately 4-6 weeks after returning the product.
Keep copies of receipts, any recall notices from the manufacturer, and correspondence regarding the return process.
The recalled product is the Disposable Triple Lumen Sphincterotome, Model/Catalog Number KD-401Q-0720. It was distributed worldwide, including all U.S. states and internationally. The devices were sold as part of Olympus endoscope systems.
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