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FDA-Device2026-02-11Class IIPROCESSING DEFECT

Olympus Single Use 3-Lumen Sphincterotome V recalled for potential deformation and performance loss

Olympus
OTHERNationwide distribution

Stop using affected Olympus sphincterotome devices

Olympus Corporation is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC411Q-0720) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and stop working as intended during medical procedures.

  • Check if your facility has this device (model KD-VC411Q-0720) with any valid expiration date
  • Stop using affected devices immediately
  • Contact Olympus Corporation of the Americas for return or replacement instructions
  • Verify the UDI or lot number with your supplier if unsure whether your inventory is affected
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
10008 units (3038 US, 6970 OUS)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-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-1278-2026

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