Olympus Corporation of the Americas recalled 125 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall affects devices that did not undergo proper thermoforming, risking deformation and performance loss. 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 recalled product is the Disposable Triple Lumen Sphincterotome, Model KD-411Q-0720. It was distributed worldwide, including in 7 units in the US and 118 units internationally. This device is designed for use with an Olympus endoscope for papillotomy.
Devices that did not undergo thermoforming may deform, leading to a loss of functionality. This poses significant risks during medical procedures, which could affect patient safety.
No specific incidents or injuries have been reported at this time. However, the potential for device deformation presents a high risk to patient safety.
Stop using the device immediately. Follow the recall instructions provided by Olympus Corporation of the Americas. Contact your healthcare provider for further instructions.
For more details, contact Olympus Corporation of the Americas at their official website or through the recall notification letter.
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