Olympus Corporation of the Americas recalled 1,980 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall affects devices that did not undergo thermoforming, risking deformation and loss of performance. Healthcare providers 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 Disposable Triple Lumen Sphincterotome is a medical instrument used in endoscopic procedures such as papillotomy. It is designed for use with an Olympus endoscope and guidewire, enabling healthcare providers to perform precise surgical actions.
The sphincterotome may deform if it did not undergo proper thermoforming. This deformation can lead to reduced performance and potential complications during medical procedures.
This recall is not part of a broader industry pattern.
The recall poses significant risks to patient safety, necessitating immediate action from healthcare providers and patients.
You can typically find the model number and other identifiers on the device packaging or insert.
Expect a realistic timeline of 4-6 weeks for processing any refunds or replacements.
Keep all purchase receipts, correspondence with the manufacturer, and any medical documentation related to the device.
The recalled product is the Disposable Triple Lumen Sphincterotome, Model/Catalog Number KD-401Q-0725. It was distributed worldwide, including nationwide in the US across multiple states. These devices are typically used with an Olympus endoscope and guidewire for papillotomy.
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