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FDA-Device2026-02-11Class IIPROCESSING DEFECT

Olympus Single Use 3-Lumen Sphincterotome V recalled for potential deformation and performance loss

Olympus
OTHERNationwide distribution

Stop using Olympus sphincterotome model KD-VC411Q-0730

Olympus Corporation of the Americas is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC411Q-0730) used in endoscopic procedures. Some devices may not have undergone proper thermoforming during manufacturing, which could cause them to deform and lose their intended performance during use.

  • If you use or stock this device, stop using it immediately and contact your Olympus representative or the FDA
  • Check your inventory for model KD-VC411Q-0730 with any valid expiration date
  • Do not use any affected units for patient procedures
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
10257 units (274 US, 9983 OUS)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-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-1279-2026

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