FDA-Device2026-02-11Class IIPROCESSING DEFECT
Olympus Single Use 3-Lumen Sphincterotome V recalled for potential device deformation
Stop using Olympus sphincterotome model KD-V411M-0725
Olympus is recalling certain batches of its Single Use 3-Lumen Sphincterotome V (model KD-V411M-0725), a surgical tool used during endoscopic procedures. Some devices may not have undergone proper manufacturing and could deform during use, affecting their performance. No injuries have been reported.
- Stop using devices with model KD-V411M-0725 immediately
- Check your inventory for material reference numbers N1089710 or N5411430
- Contact Olympus or your hospital supply department for instructions on returning or replacing affected units
- Do not reuse or redistribute recalled devices
Hazard
Devices which did not undergo thermoforming could deform and lose performance.
Who it affects
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
136037 units (9959 US, 126078 OUS)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1273-2026More Olympus recalls
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