Olympus Corporation of the Americas recalled 650 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 should 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 device designed for use with Olympus endoscopes during papillotomy procedures. Healthcare providers choose this device for its precision in biliary procedures.
Improper thermoforming can lead to deformation of the device, which may compromise its performance during critical medical procedures. This risk is significant in clinical settings where device reliability is crucial.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers who rely on these devices for safe and effective patient care. Immediate action is necessary to prevent potential risks during medical procedures.
Model numbers can be found on the packaging and accompanying documentation.
Expect processing for refunds or replacements to take 4-6 weeks after submission.
Keep records of receipts, correspondence with Olympus, and photos of the product as evidence for your records.
The affected product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V411M-3020. Olympus distributed this product Worldwide, including 50 states in the US. The recall affects 650 units.
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