FDA-Device2026-02-11Class IIPROCESSING DEFECT
Olympus Disposable Triple Lumen Sphincterotome KD-401Q-0725 recalled for potential device deformation
What this means
Olympus has recalled certain Disposable Triple Lumen Sphincterotomes (model KD-401Q-0725) used in endoscopic procedures. Some devices may not have undergone proper manufacturing steps and could deform or lose performance during use.
- Stop using any Olympus sphincterotome model KD-401Q-0725 immediately
- Contact Olympus Corporation of the Americas for device return or replacement instructions
- Check your facility's inventory for affected lot numbers and verify expiration dates
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
1980 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-0725 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-1294-2026More Olympus recalls
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