Olympus Corporation of the Americas recalled 1,025 units of its Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform due to inadequate thermoforming, posing a high hazard level. Patients and healthcare providers must stop using the devices 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/Catalog Number: KD-V411M-3025. The product was distributed worldwide, including all U.S. states, with a total quantity of 1,025 units.
Devices that did not undergo proper thermoforming can deform, leading to potential loss of performance during medical procedures. This defect poses a significant risk to patient safety.
No specific incidents or injuries have been reported to date related to this recall. However, the potential for device failure during use is deemed a high hazard.
Stop using the device immediately. Healthcare providers should follow the recall instructions provided by Olympus. For further information, contact Olympus Corporation of the Americas.
For more details, call Olympus Corporation of the Americas or visit the recall page at the FDA website.
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