Recall Weekly← all recalls
FDA-Device2026-02-11Class IIPROCESSING DEFECT

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

Olympus
OTHERNationwide distribution

Stop using Olympus KD-V411M-1530 sphincterotome

Olympus is recalling certain Single Use 3-Lumen Sphincterotome V devices (model KD-V411M-1530) used in endoscopic procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and lose performance during use.

  • Stop using any Olympus KD-V411M-1530 sphincterotomes in your facility immediately
  • Check your inventory for affected lots (all lots with valid expiration dates)
  • Contact Olympus Corporation of the Americas for device replacement or guidance
  • Return unused recalled devices per Olympus instructions
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
7046 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-1530 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-1291-2026

More Olympus Corporation of the Americas recalls

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief