FDA-Device2026-02-11Class IIPROCESSING DEFECT
Olympus KD-V411M-3030 sphincterotome recalled for deformation risk
What this means
Olympus Corporation is recalling certain single-use 3-lumen sphincterotomes (model KD-V411M-3030) used in endoscopic procedures. Some devices may not have undergone proper thermoforming during manufacturing, which could cause them to deform and fail to work correctly during use.
- Stop using any Olympus KD-V411M-3030 sphincterotomes currently in stock
- Check your inventory for affected lot numbers (all lots with valid expiration dates)
- Contact Olympus Corporation of the Americas for instructions on return or replacement
- Review patient records if devices were already used and consult with your medical team about any follow-up needs
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
2344 units (OUS only)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 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-1292-2026More Olympus recalls
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- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
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