Z-1294-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 11, 2026
- Initiation Date
- January 7, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1980 units (OUS only)
Product Description
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 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.
Distribution Pattern
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.
Code Information
Model/Catalog Number: KD-401Q-0725; Material REF: 5856930; UDI-DI: 04953170041587; All Lots with a valid expiration date