Product Name: Disposable Triple Lumen Sphincterotome Model/catalog Number: Kd-401q-0730 Product Description: These Instruments Have Been Designed To Be Used With An Olympus Endoscope And Guidewire For

Recall Summary Olympus is recalling Disposable Triple Lumen Sphincterotomes (model KD-401Q-0730) used in endoscopic procedures because some devices 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 be used with Olympus endoscopes for papillotomy procedures.

Recalling firm

Olympus Corporation of the Americas

Product

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 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/8eef0129-34a7-49d4-a165-be538ddc485b