Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Recalled by Olympus Corporation of the Americas Due to Devices which did not undergo thermoforming could deform...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Olympus Corporation of the Americas directly.
Affected Products
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Quantity: 1504 units (350 US, 1154 OUS)
Why Was This Recalled?
Devices which did not undergo thermoforming could deform and lose performance.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Olympus Corporation of the Americas
Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report