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FDAJanuary 7, 2026device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Devices which did not undergo thermoforming could deform and lose performance.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

04953170371219

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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