FDA-Device2026-02-11Class IIPROCESSING DEFECT
Olympus Single Use 3-Lumen Sphincterotome V recalled for potential device deformation
What this means
Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-V411M-0720) used in endoscopy procedures. Some devices may not have been properly heat-treated during manufacturing, which could cause them to deform and stop working as intended during use.
- Stop using any Olympus Single Use 3-Lumen Sphincterotome V model KD-V411M-0720 devices immediately
- Contact your facility's equipment or procurement team to identify affected units
- Check the lot number and expiration date on your devices against Olympus's recall list
- Return or dispose of recalled devices according to your facility's protocol and Olympus instructions
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
65117 units (9707 US, 55410 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-0720; 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-1272-2026More 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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