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Medium risk Medical DevicesClass II

Olympus Sphincterotome Recall KD-401Q

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been des

Updated January 7, 2026

Olympus Disposable Triple Lumen Sphincterotome Model KD-401Q-0330 may deform and lose performance if it was not properly thermoformed during manufacturing. This could affect the device's ability to perform papillotomy procedures safely.

Is the Olympus Corporation of the Americas recalled? Yes. This product was recalled by FDA on January 7, 2026. Details below.

What is recalled

Olympus Disposable Triple Lumen Sphincterotome, Model/Catalog Number KD-401Q-0330. These are single-use devices designed for use with Olympus endoscopes and guidewires for papillotomy procedures.

Am I affected

You are affected if you have a Disposable Triple Lumen Sphincterotome Model KD-401Q-0330. Check the model number on the device packaging or labeling. Healthcare facilities that stock or use this model should verify their inventory.

What to do right now

Stop using this device immediately. Contact Olympus Corporation of the Americas to report your inventory and receive instructions on return or replacement of affected units.

The hazard

Devices which did not undergo thermoforming could deform and lose performance.

Brands affected

Olympus Corporation of the Americas
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1287-2026
Classification
Class II
Recalled
January 7, 2026
Read the official notice

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