Pentax of America product recalled over fire hazard

Recall date

January 29, 2025

Source

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

Official notice title

Pentax of America Inc recalls PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic…

Recall number

Z-1237-2025

FDA classification

Class II

Brand / firm

Pentax of America Inc

Sold / distributed

Nationwide

Why it was recalled

During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). 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 membranes.

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 Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c