Olympus Corporation of the Americas recalled 2,344 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform due to improper thermoforming, leading to performance issues. This recall affects units distributed worldwide, including all U.S. states.
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 Single Use 3-Lumen Sphincterotome V is a medical instrument designed for use in endoscopic procedures, specifically for papillotomy using high-frequency current. It is often used in hospitals and medical facilities during surgical procedures.
The risk arises from devices that did not undergo proper thermoforming, which may lead to deformation. Deformed devices can compromise the safety and effectiveness of medical procedures, posing significant risks to patients.
This recall is not part of a broader industry pattern.
Consumers using this device should stop immediately to avoid potential complications during medical procedures. The recall does not currently indicate any injuries, but the high-risk classification highlights the urgency for action.
The model number and expiration date can typically be found on the packaging or the device itself.
Expect a refund or replacement process to take approximately 4-6 weeks.
Keep all receipts, correspondence regarding the recall, and photos of the product as records.
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number: KD-V411M-3030. The device is designed for use with an Olympus endoscope and guidewire for papillotomy using high-frequency current. It was distributed worldwide, including various states across the U.S.
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