Pentax Medical Video Processor recalled over fire hazard

Recall date

July 16, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pentax of America Inc recalls Pentax Medical Video Processor; Model Number: EPK-i8020c;

Recall number

Z-2329-2025

FDA classification

Class II

Brand / firm

Pentax of America Inc

Sold / distributed

US Distribution to states of: AZ, CA, DC, FL IA, ID, IL, KS, MA, MD, MI, MO, NC, NJ, NM, NY, OK, PA, TX, WA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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