Recall Z-1296-2026— Olympus Corporation of the Americas

Name: FDA recall Z-1296-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-07

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2026-01-07. It names one FDA 510(k) clearance: K950166. Product: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 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..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2026-01-07
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K950166 — OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFEOlympus America, Inc.·cleared 1995-02-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.