Product Name: Single Use 3-lumen Sphincterotome V (distal Wire Guided) Model/catalog Number: Kd-vc411q-0320; Software Version: N/a Product Description: These Instruments Have Been Designed To Be Used

Recall Summary Olympus is recalling Single Use 3-Lumen Sphincterotome V devices (Model KD-VC411Q-0320) used during endoscopic procedures. Some devices may not have been properly formed during manufacturing and could deform or stop working correctly during use. This recall affects the specific model listed and was classified as a Class II recall.

Recalling firm

Olympus Corporation of the Americas

Product

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; 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/f027107f-1841-4cd5-8e14-cdba7ad7604f