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FDA-Device2026-02-11Class IIPROCESSING DEFECT

Olympus Disposable Triple Lumen Sphincterotome (KD-411Q-0720) recalled for potential deformation

Olympus
OTHERNationwide distribution

Stop using Olympus sphincterotome model KD-411Q-0720

Olympus Corporation of the Americas is recalling certain Disposable Triple Lumen Sphincterotomes (model KD-411Q-0720) used during endoscopy procedures. Some devices may not have undergone proper manufacturing and could deform during use, which would cause them to stop working correctly.

  • Stop using any Olympus sphincterotome model KD-411Q-0720 with material reference 5858030 immediately
  • Contact your healthcare facility's procurement or equipment management department to identify affected devices
  • Return unused devices to Olympus or your supplier for replacement or 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
125 units (7 US, 118 OUS)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-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-1285-2026

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