Product Name: Single Use 3-lumen Sphincterotome V Model/catalog Number: Kd-v411m-0725; Software Version: N/a Product Description: These Instruments Have Been Designed To Be Used With An Olympus Endos

Recall Summary Olympus is recalling Single Use 3-Lumen Sphincterotome V devices (model KD-V411M-0725) used during endoscopy procedures because some units may not have been properly heat-formed during manufacturing, which could cause them to deform and not work as intended. The devices are designed to work with Olympus endoscopes to perform papillotomy procedures using electrical current. 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-0725; Software Version: N/A 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/7c9c2401-bf20-48a1-a223-8d1317b1e734