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-V411M-0720
Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-V411M-0720) used in endoscopy procedures. Some devices may not have been properly heat-treated during manufacturing, which could cause them to deform and stop working as intended during use.
- Stop using any Olympus Single Use 3-Lumen Sphincterotome V model KD-V411M-0720 devices immediately
- Contact your facility's equipment or procurement team to identify affected units
- Check the lot number and expiration date on your devices against Olympus's recall list
- Return or dispose of recalled devices according to your facility's protocol and Olympus instructions
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
65117 units (9707 US, 55410 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-0720; 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-1272-2026More 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
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief