Pentax recalls EPK-i8020c video processors used with endoscopes due to rare reddish image and potential thermal injury to patient mucous membranes during procedures.
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.
Pentax is recalling specific EPK-i8020c medical video processors that can cause reddish images and hot light guides during endoscopic procedures, potentially injuring patient mucous membranes. This risk occurs during normal use with certain endoscopes and requires immediate action to prevent harm.
During endoscopic procedures, the video processor can produce reddish or dark images in 1.8% of cases. Users have reported smoke-like steam and hot light guides at the endoscope tip, which may cause thermal injury to the patient's mucous membranes.
Healthcare providers using Pentax EPK-i8020c video processors with i20c endoscopes for medical procedures. Patients undergoing endoscopy with these specific devices are at risk of mucous membrane injury.
Check for model number EPK-i8020c on the device. Serial numbers include B0023Z1193 through B0023Z1717 and other listed numbers. These processors were sold with Pentax Medical endoscopes for diagnostic and treatment procedures.
Discontinue use of the recalled EPK-i8020c video processor with i20c endoscopes to prevent potential thermal injury to patient mucous membranes.
The recalled model is EPK-i8020c with specific serial numbers listed in the recall notice.
The issue occurs in 1.8% of cases during endoscopic procedures using the combination of the video processor and i20c endoscope.
The recall does not mention repair options; users must stop using the device immediately to prevent potential injury.
We’ve drafted a message you can send Pentax to request your refund or repair — edit it as you like.
Subject: Recall Z-1238-2025 — Pentax Pentax Hello, I own a Pentax that is covered by recall Z-1238-2025 from Pentax. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
