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FDA-Device2026-02-11Class IIPROCESSING DEFECT

Olympus Disposable Triple Lumen Sphincterotome (KD-401Q-0320) recalled for potential deformation

Olympus
OTHERNationwide distribution

Stop using Olympus sphincterotome model KD-401Q-0320

Olympus Corporation of the Americas is recalling certain Disposable Triple Lumen Sphincterotomes (model KD-401Q-0320) used in endoscopic procedures. Some devices may not have undergone proper heat treatment and could deform during use, affecting their ability to perform correctly.

  • Stop using model KD-401Q-0320 sphincterotomes immediately
  • Check the model and catalog number on your devices
  • Contact your Olympus representative or the company for return or replacement instructions
  • Review affected lot numbers if you have inventory records
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
999 units (OUS only)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 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-1293-2026

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