FDA-Device2026-02-11Class IIPROCESSING DEFECT
Olympus KD-401Q-0730 sphincterotome recalled for potential deformation during use
What this means
Olympus has recalled certain Disposable Triple Lumen Sphincterotome devices (Model KD-401Q-0730) because some units may not have undergone proper manufacturing. These devices could deform during use and may not perform as intended during papillotomy procedures.
- Check your facility's inventory for Model KD-401Q-0730 sphincterotomes with Material REF 5857030
- Do not use any affected devices; contact your Olympus distributor for replacement instructions
- Verify the device serial number and expiration date against Olympus's list of affected lots
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
1490 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-0730 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-1289-2026More Olympus recalls
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