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FDA-Device2026-02-11Class IIPROCESSING DEFECT

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

Olympus
OTHERNationwide distribution

Stop using Olympus sphincterotome model KD-VC433Q-0730

Olympus has recalled certain Single Use 3-Lumen Sphincterotome V devices (model KD-VC433Q-0730) used in endoscopic procedures because some units did not undergo proper thermoforming during manufacturing. These devices may deform and lose performance during use.

  • Check your inventory for model KD-VC433Q-0730 with any valid expiration date
  • Stop using any affected devices immediately
  • Contact Olympus Corporation of the Americas for return and replacement instructions
  • Review your records to identify patients who may have received this device and consult with your medical team as needed
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
93 units (5 US, 88 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-VC433Q-0730; 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-1284-2026

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