Product Name: Single Use 3-lumen Sphincterotome V Model/catalog Number: Kd-v411m-1530 Product Description: These Instruments Have Been Designed To Be Used With An Olympus Endoscope And Guidewire For P

Recall Summary Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Model KD-V411M-1530), a medical device used during endoscopic procedures to cut tissue. Some devices may not have been properly formed during manufacturing, which could cause them to deform and not work as intended. This is a Class II recall affecting the medical device.

Recalling firm

Olympus Corporation of the Americas

Product

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Reason

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

Classification

Class II

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-01-07

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/1425d2cf-72fa-4fef-a4a7-72d6803e4fa0