Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V

Recalling company

Olympus Corporation of the Americas

Product

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; 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 – may cause temporary or medically reversible health consequences

Recall date

Jan 7, 2026

Reported

Feb 11, 2026

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.

Status

Ongoing

Quantity

86303 units (1803 US, 84500 OUS)

Lot / codes

Model/Catalog Number: KD-V411M-0730; Material REF: (1) N1089810, (2) N5411530; UDI-DI: (1) 04953170380594, (2) 04953170380594; All Lots with a valid expiration date

Company location

Center Valley, PA

Recall type

Voluntary: Firm initiated

Recall number

Z-1274-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1274-2026 in the FDA Enforcement Report. Also see FDA recall press releases.