FDA-Device2026-02-11Class IIPROCESSING DEFECT
Olympus Single Use 3-Lumen Sphincterotome V recalled for potential device deformation
What this means
Some Olympus sphincterotome devices (model KD-V411M-0330) may not have been properly processed during manufacturing. Devices that skipped a key heating step could deform and fail to work correctly during medical procedures.
- Stop using any affected sphincterotome devices immediately
- Check your inventory for model KD-V411M-0330 with the listed material reference numbers
- Contact Olympus Corporation of the Americas for instructions on device return or replacement
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
33433 units (36 US, 33397 OUS)
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-0330; Software Version: N/A 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-1271-2026More Olympus recalls
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- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
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