Olympus Corporation of the Americas — Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Description: These instruments have been designed to
⚠️ 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 Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 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-VC431Q-0720; Material REF: (1) N5391530, (2) N5391510, (3) N5777830; UDI-DI: (1) 04953170466427, (2) 04953170466427, (3) 04953170466427; All Lots with a valid expiration date
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 12641 units (8789 US, 3852 OUS).
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