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Medium risk Medical DevicesClass II

Olympus Sphincterotome V Device Recall

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been desig

Updated January 7, 2026

Olympus Single Use 3-Lumen Sphincterotome V devices may deform and lose performance if they were not properly thermoformed during manufacturing. These instruments are used during endoscopy procedures to cut tissue, and a deformed device could fail during use.

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 Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V411M-1520.

Am I affected

You're affected if you use or have received this device in a medical facility and the device model number is KD-V411M-1520. Check with your hospital or procedure center to confirm whether any affected units were used.

What to do right now

If you work in a medical facility that uses this device, stop using any units with model number KD-V411M-1520 and contact Olympus Corporation of the Americas or your equipment supplier for instructions on replacement or verification of your inventory.

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-1290-2026
Classification
Class II
Recalled
January 7, 2026
Read the official notice

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