Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
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Recall Number
Z-1296-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2026-01-07
Reported
2026-02-11
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.
Code Info
Model/Catalog Number: KD-V411M-3025; Material REF: N1090210; UDI-DI: N/A; All Lots with a valid expiration date
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.