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 Single Use 3-Lumen Sphincterotome V is designed for use with Olympus endoscopes in papillotomy procedures. It utilizes high-frequency current to perform the procedure effectively.
The devices may deform if they did not undergo proper thermoforming, which can lead to malfunction during critical medical procedures. This could compromise patient safety and treatment effectiveness.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers and patients who rely on these devices for endoscopic procedures. Users must act promptly to avoid potential risks and ensure safety.
The model number is typically found on the product packaging or directly on the device.
Expect processing for refunds or replacements to take approximately 4-6 weeks.
Keep records of purchase receipts, recall notices, and correspondence with Olympus for reference.
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.
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