Product Name: Single Use 3-lumen Sphincterotome V Model/catalog Number: Kd-v411m-1520 Product Description: These Instruments Have Been Designed To Be Used With An Olympus Endoscope And Guidewire For P

Recall Summary Olympus is recalling Single Use 3-Lumen Sphincterotome V devices (Model KD-V411M-1520) used during endoscopic procedures because some units may not have been properly heat-formed during manufacturing, which could cause them to deform and not work as intended. This is a Class II recall affecting medical devices designed to work with Olympus endoscopes for a procedure called papillotomy.

Recalling firm

Olympus Corporation of the Americas

Product

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 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/128a32ee-9d2f-43ea-bf8a-e5448ac61b24