FDA-Device2026-02-11Class IIPROCESSING DEFECT
Olympus Single Use 3-Lumen Sphincterotome V recalled for potential device deformation
OTHERNationwide distribution
Stop using Olympus sphincterotome model KD-V431M-0730
Olympus has recalled certain single-use sphincterotome devices (model KD-V431M-0730) used during endoscopy procedures. Some devices may not have been properly formed during manufacturing and could deform or fail to work as intended during use.
- Stop using any Olympus sphincterotome model KD-V431M-0730 immediately
- Contact your healthcare facility's device management or procurement team
- Return unused devices to Olympus or your distributor
- Check all lot numbers against Olympus's recall list
Hazard
Devices which did not undergo thermoforming could deform and lose performance.
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
17655 units (2411 US, 15244 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-V431M-0730; 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-1276-2026More Olympus Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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