FDA-Device2026-02-11Class IIPROCESSING DEFECT
Olympus Single Use Sphincterotome V recalled for potential device deformation
What this means
Olympus has recalled certain Single Use Sphincterotome V devices (model KD-VC431Q-0720) used in endoscopic procedures. Some devices in this batch may not have been properly heat-formed during manufacturing, which could cause them to deform and stop working correctly during use. No injuries have been reported.
- Stop using any Sphincterotome V model KD-VC431Q-0720 devices in your facility immediately
- Check your inventory for devices with material reference numbers N5391530, N5391510, or N5777830
- Contact Olympus Corporation of the Americas for instructions on device replacement or return
- Consult the FDA recall notice or your device supplier for a complete list of affected lot numbers
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
12641 units (8789 US, 3852 OUS)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 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-1269-2026More Olympus recalls
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