Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-1289-2026

U.S. FDA — Device Enforcement · United States · 2026-01-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1289-2026
Date of alert
2026-01-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Olympus Corporation of the Americas
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04953170041709
Reported risk: Devices which did not undergo thermoforming could deform and lose performance.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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