Olympus Corporation of the Americas — Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instruments have been
⚠️ Devices which did not undergo thermoforming could deform and lose performance.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 7, 2026
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.
What's affected?
- Product
- Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-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.
- Lot code
- with
Additional details
Model/Catalog Number: KD-V411M-0725; Material REF: (1) N1089710, (2) N5411430; UDI-DI: (1) 04953170380587, (2) 04953170380587; All Lots with a valid expiration date
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 136037 units (9959 US, 126078 OUS).
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