Olympus Corporation of the Americas recalled 93 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform and lose performance due to a manufacturing flaw. Healthcare providers and patients should stop using the device 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 Single Use 3-Lumen Sphincterotome V, Model Number KD-VC433Q-0730. It was designed for use with Olympus endoscopes for papillotomy. The devices were distributed worldwide, including across multiple U.S. states.
The recalled sphincterotome may deform if it did not undergo proper thermoforming. This deformation can lead to a loss of performance during medical procedures, posing a high risk to patient safety.
No specific incidents or injuries have been reported related to this recall. However, the potential for performance loss raises significant concerns for healthcare providers.
Patients and healthcare providers should stop using the sphincterotome immediately. Contact Olympus Corporation of the Americas or your healthcare provider for instructions on returning the device.
For more information, contact Olympus Corporation at 1-800-848-9024 or visit the recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1284-2026.
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