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FDAJuly 16, 2025device

Pentax Medical Video Processor; Model Number: EPK-i8020c;

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

The hazard

During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane.

What to do

FDA enforcement status: Ongoing

Brands named

pentax

UPCs

04961333247974

Recall history

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

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