Olympus Corporation of the Americas recalled 125 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall affects devices that did not undergo proper thermoforming, risking deformation and performance loss. Healthcare providers must stop using these 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 Disposable Triple Lumen Sphincterotome is a medical instrument used for papillotomy procedures. It is designed for use with an Olympus endoscope to facilitate the safe removal of stones from the bile duct.
The devices may not have undergone proper thermoforming, leading to potential deformation. This can compromise their effectiveness and safety during medical procedures.
This recall is not part of a broader industry pattern.
The recall necessitates immediate action from healthcare providers and patients, potentially disrupting scheduled procedures and affecting patient care.
You can find the model number and expiration date on the packaging or the product itself.
A realistic timeline for processing refunds or replacements is typically 4-6 weeks.
Keep all correspondence regarding the recall, including emails, letters, and any documentation related to the purchase and use of the device.
The recalled product is the Disposable Triple Lumen Sphincterotome, Model KD-411Q-0720. It was distributed worldwide, including in 7 units in the US and 118 units internationally. This device is designed for use with an Olympus endoscope for papillotomy.
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