Olympus Corporation of the Americas recalled 17,655 sphincterotomes on January 7, 2026. The devices may deform due to improper thermoforming, affecting performance. Patients and healthcare providers must stop using the 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 recall involves Single Use 3-Lumen Sphincterotome V, Model KD-V431M-0730. Olympus distributed 2,411 units in the U.S. and 15,244 units internationally.
The sphincterotomes may deform and lose performance due to a failure in the thermoforming process. This defect poses a high risk in medical procedures where device integrity is crucial.
There are no specific incident reports or injuries linked to the recalled devices at this time. The risk remains significant due to the nature of the medical applications.
Stop using the device immediately. Contact Olympus Corporation of the Americas or your healthcare provider for specific instructions regarding the recall.
For further assistance, patients can reach Olympus at their customer service number or visit their website for additional recall instructions.
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