FDAHealthJanuary 7, 2026
Olympus Corporation of the Americas — Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product Description:
⚠️ 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
- Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 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-401Q-0320; Material REF: 5856630; UDI-DI: 04953170041587; All Lots with a valid expiration date
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 999 units (OUS only).
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