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Pentax of America Inc recalls Pentax Medical Video Processor; Model Number: EPK-i8020c;
Recalled August 27, 2025 · FDA recall Z-2329-2025 · Pentax of America
Hazard
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. · FDA Class II
Units
144 units
Sold at
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.
Description
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.
Product
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Manufacturer(s)
Pentax of America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →