FDA-Device2026-02-11Class IIPROCESSING DEFECT
Olympus Disposable Triple Lumen Sphincterotome (KD-401Q-0320) recalled for potential deformation
What this means
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
The agency's original wording
Hazard
Devices which did not undergo thermoforming could deform and lose performance.
Intended for
Adults
Illnesses reported
None reported
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-1293-2026More Olympus recalls
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- FDA-Device2026-07-22Olympus Toomey Evacuator 50cc Model 188A recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
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