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FDA-Device2026-02-11Class IIPROCESSING DEFECT

Olympus Disposable Triple Lumen Sphincterotome (KD-431Q-0720) recalled for potential deformation

Olympus
OTHERNationwide distribution

Stop using Olympus sphincterotome KD-431Q-0720

Olympus has recalled certain Disposable Triple Lumen Sphincterotomes (model KD-431Q-0720) used in endoscopic procedures because some devices may not have been properly heat-treated during manufacturing. Affected devices could deform and lose their intended performance during use.

  • Check if you have this device (model KD-431Q-0720) in your facility.
  • Stop using affected units immediately.
  • Contact your Olympus representative or the FDA for instructions on returning or replacing the device.
  • Review patient records if this device was already used.
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
7689 units (7501 US, 188 OUS)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 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-1270-2026

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