Stop using nowMedical device recall · FDA · Published July 16, 2025
Pentax EPK-i8020c Medical Video Processor Recall: Reddish Image and Thermal Risk
Pentax recalls EPK-i8020c medical video processors after users reported reddish images and hot light guides causing potential mucous membrane burns during endoscopy.
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.
Take action
Contact the company
📍Recalling firmPentax of America Inc3 Paragon Dr · Montvale, NJ 07645-1782
“Pentax EPK-i8020c Medical Video Processor Recall: Reddish Image and Thermal Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51782-pentax-epk-i8020c-medical-video-processor-recall-reddish-image-and. Based on FDA recall #Z-2329-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2329-2025%22&limit=1).
The FDA announced on July 16, 2025, that Pentax of America Inc is recalling its Pentax Medical Video Processor, model EPK-i8020c, due to a thermal injury hazard. The device may overheat during use, potentially causing burns to patients' mucous membranes.
How to tell if you have it
Brand: Pentax
Product: Pentax Medical Video Processor
Model Number: EPK-i8020c
Units affected: 144
The hazard
According to the FDA, 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 or after the endoscope is removed from the patient, which may cause thermal injury to the patient's mucous membrane.
Context
GovInfoNow's records show Pentax of America Inc has 10 other recalls on record since July 13, 2017. Other recent recalls of similar products include Pentax Medical Colonoscope Recall (Jan. 29, 2025), Pentax Video Colonoscopes Recall (July 14, 2021), and Pentax Medical Duodenoscope Recall (April 21, 2021).
How to tell if you have this one
Check for the model number EPK-i8020c on the device. Serial numbers listed in the recall include many starting with B0023Z, C0023Z, D0023Z, or E0023Z prefixes.
Brand
Pentax
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately stop using the EPK-i8020c video processor with i20c endoscopes during procedures as it can cause burns to patients' mucous membranes.
Where it went and when
Where it was distributed
Distributed in 19 states and D.C..
Listed by the agency
Not listed
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, District of Columbia, Florida, Idaho, Illinois, Iowa, Kansas, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Pennsylvania, Texas, Washington.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2329-2025 (July 16, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2329-2025 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.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.