Product Name: Disposable Triple Lumen Sphincterotome Model/catalog Number: Kd-401q-0720 Product Description: These Instruments Have Been Designed To Be Used With An Olympus Endoscope And Guidewire For

Recall Summary Olympus Corporation is recalling Disposable Triple Lumen Sphincterotome devices (model KD-401Q-0720) used during endoscopic procedures. Some devices may not have been properly formed during manufacturing and could deform or fail to work correctly during use. This recall affects medical facilities and hospitals that use these instruments with Olympus endoscopes.

Recalling firm

Olympus Corporation of the Americas

Product

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 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/65731377-9898-46ca-8920-d7babbbc055c