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FDA-Device2026-02-11Class IIPROCESSING DEFECT

Olympus Single Use 3-Lumen Sphincterotome V recalled for potential device deformation

Olympus
OTHERNationwide distribution

Stop using Olympus sphincterotome model KD-V411M-1520

Olympus has recalled certain Single Use 3-Lumen Sphincterotome V devices (model KD-V411M-1520) used during endoscopic procedures. Some units may not have been properly heat-formed during manufacturing, which could cause them to deform and stop working as intended.

  • Stop using affected devices immediately if you have them in stock.
  • Check your inventory for model KD-V411M-1520 with material ref N5411630 or N1089910.
  • Contact Olympus Corporation of the Americas for instructions on returning or replacing affected units.
  • Verify device lot numbers and expiration dates against recall notices before use.
Hazard

Devices which did not undergo thermoforming could deform and lose performance.

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
3954 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-1520 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-1290-2026

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