FDA-Device2026-02-11Class IIPROCESSING DEFECT
Olympus Disposable Triple Lumen Sphincterotome recalled for potential deformation and loss of performance
What this means
Olympus Corporation of the Americas is recalling certain Disposable Triple Lumen Sphincterotomes (model KD-401Q-0720) used during endoscopic procedures. Some devices may not have undergone proper manufacturing and could deform during use, which may cause them to lose their intended performance.
- Check if you have sphincterotome model KD-401Q-0720 with material reference 5856830
- Stop using affected devices immediately
- Contact your Olympus representative or facility's medical device coordinator for instructions on replacement or return
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
1072 units (OUS only)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-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-1288-2026More Olympus recalls
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