Olympus Corporation recalled 887 units of the Disposable Triple Lumen Sphincterotome on January 7, 2026. The devices may deform and lose performance if not properly thermoformed. The recall affects both US and international markets.
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 Number KD-411Q-0730. It was distributed worldwide, with 650 units sold in the United States and 237 units internationally.
The devices may deform and lose performance if they did not undergo thermoforming. This defect creates a high hazard risk, potentially leading to ineffective medical procedures.
No specific incidents or injuries have been reported related to this recall. The risk remains high due to the potential for device malfunction.
Stop using the device immediately. Follow the recall instructions provided by Olympus Corporation of the Americas and contact your healthcare provider.
For more information, contact Olympus Corporation of the Americas or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1286-2026.
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