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FDA-Device2026-02-11Class IIPROCESSING DEFECT

Olympus Disposable Triple Lumen Sphincterotome recalled for potential deformation

Olympus
OTHERNationwide distribution

Stop using Olympus KD-411Q-0730 sphincterotome

Olympus has recalled certain Disposable Triple Lumen Sphincterotomes (model KD-411Q-0730) used during endoscopic procedures. Some devices may not have been properly heat-treated during manufacturing, which could cause them to deform and not work as intended during use.

  • Stop using any Olympus KD-411Q-0730 sphincterotomes in your facility immediately
  • Contact your Olympus representative or the FDA for instructions on returning or destroying affected units
  • Check your inventory against the affected material reference numbers and UDI codes listed in the recall notice
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
887 units (650 US, 237 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-0730 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-1286-2026

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