FDA-Device2026-02-11Class IIPROCESSING DEFECT
Olympus KD-401Q-0330 sphincterotome recalled for potential deformation and performance loss
What this means
Olympus Corporation has recalled certain Disposable Triple Lumen Sphincterotome devices (model KD-401Q-0330) used in endoscopic procedures. Some devices may not have undergone proper thermoforming, which could cause them to deform and fail to perform as intended during use.
- Check your facility's inventory for model KD-401Q-0330 devices with the material reference 5856730
- Do not use any affected devices for procedures
- Contact Olympus Corporation of the Americas for device return or replacement instructions
- Verify your devices were not part of the recall by checking the lot number and expiration date
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
886 units (OUS only)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 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-1287-2026More Olympus recalls
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