Use cautionMedical device recall · FDA · Published January 29, 2025
Pentax Medical Video Processor Recall: Reddish Image Risk of Thermal Injury
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.
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📍Recalling firmPentax of America Inc3 Paragon Dr · Montvale, NJ 07645-1782
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/53016-pentax-medical-video-processor-recall-reddish-image-risk-of-thermal.
“Pentax Medical Video Processor Recall: Reddish Image Risk of Thermal Injury.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/53016-pentax-medical-video-processor-recall-reddish-image-risk-of-thermal. Based on FDA recall #Z-1238-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1238-2025%22&limit=1).
The FDA announced on Jan. 29, 2025, that Pentax of America Inc is recalling its EPK-i8020c Medical Video Processor due to potential thermal injury risks during endoscopic procedures. Owners should stop using the device immediately.
During endoscopic procedures using the EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark in 1.8% of cases. Users have reported smoke-like steam and noted that the light guide at the tip becomes hot during use or after removal from the patient, potentially causing thermal injury to mucous membranes.
Context
GovInfoNow's records show Pentax of America Inc has issued 10 other recalls since July 13, 2017. On July 16, 2025, the company recalled the EPK-i8020c Medical Video Processor for similar reddish image and thermal risks. Other recent recalls of similar products include the Pentax Video Colonoscopes Recall (July 14, 2021), the Pentax Medical Duodenoscope Recall (April 21, 2021), the Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026), the Olympus Single Use Sphincterotome V Recall (Jan. 7, 2026), and the Canon Alphenix INFX-8000H X-ray System Recall (Dec. 19, 2025).
How to tell if you have this one
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.
Brand
Pentax
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
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.
Official source: FDA Recall #Z-1238-2025 (January 29, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1238-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
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