Olympus Corporation of the Americas recalled 999 units of the Disposable Triple Lumen Sphincterotome on January 7, 2026. Devices may deform and lose performance due to improper thermoforming. Patients and healthcare providers should stop using the product 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 model is the KD-401Q-0320, which is designed for use with Olympus endoscopes and guidewires for papillotomy. The recall affects 999 units distributed worldwide, including across multiple U.S. states.
The sphincterotome can deform if it did not undergo proper thermoforming, impacting its performance during use. This defect poses a high risk to patient safety in medical procedures.
Healthcare providers and patients should stop using the device immediately. Follow the recall instructions from the manufacturer and contact Olympus Corporation for guidance.
For more information, contact Olympus Corporation of the Americas. Visit the recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1293-2026.
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