Product Name: Disposable Triple Lumen Sphincterotome Model/catalog Number: Kd-401q-0725 Product Description: These Instruments Have Been Designed To Be Used With An Olympus Endoscope And Guidewire For

Recall Summary Olympus Corporation of the Americas is recalling Disposable Triple Lumen Sphincterotome devices (Model KD-401Q-0725) used in endoscopic procedures because some units may not have been properly manufactured through a thermoforming process, potentially causing them to deform and malfunction during use. The affected devices were designed to work with Olympus endoscopes for a specific procedure using high-frequency electrical current. This is classified as a Class II recall, which indicates a serious but not immediately life-threatening situation.

Recalling firm: Olympus Corporation of the Americas
Product: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 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

Recall details on Nibble Recalls: https://trynibble.app/recalls/18e1261d-9d35-44e9-8f43-48030b16ef4a