Medical Device Recall: Pentax Medical Video Processor; Model Number: EPK-i8020c;
Pentax of America Inc · July 16, 2025
Reason for Recall
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.
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 Affected
AZ, CA, DC, FL, IA, ID, IL, KS, MA, MD, MI, MO, NC, NJ, NM, NY, OK, PA, TX, WA
Quantity Affected
144 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2329-2025
Status: ongoing
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