Olympus Corporation recalled 1,474 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform and lose performance due to improper thermoforming. Healthcare providers and patients must stop using these instruments 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 Single Use 3-Lumen Sphincterotome V is a medical instrument designed for use with Olympus endoscopes for performing papillotomy. It is typically used in surgical procedures to facilitate access to the bile duct.
Devices that did not undergo proper thermoforming may deform, leading to performance issues during medical procedures, which can jeopardize patient safety.
This recall is not part of a broader industry pattern.
The recall requires immediate attention from healthcare providers and may lead to temporary disruptions in medical procedures.
The model number can usually be found on the packaging or directly on the device itself.
Expect a timeline of 4-6 weeks for processing refunds or replacements after following the recall instructions.
Keep a record of the device's model number, purchase date, and any correspondence with the manufacturer.
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-VC411Q-0725. It was distributed worldwide, including all states in the U.S. The devices were designed for use with Olympus endoscopes for papillotomy.
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