Class IIReported 2026-02-11

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-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.

Recalled by Olympus Corporation of the Americas

Reason for Recall

Devices which did not undergo thermoforming could deform and lose performance.

Recall Number

Z-1297-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2026-01-07

Reported

2026-02-11

Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.

Code Info

Model/Catalog Number: KD-VC411Q-0725; Material REF: N5424710; UDI-DI: N/A; All Lots with a valid expiration date

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.