Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pentax Medical Video Processor Recalled by Pentax of America Inc Due to During endoscopic procedures using a combination of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Pentax of America Inc directly.
Affected Products
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Quantity: 144 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 20 states: AZ, CA, FL, ID, IL, IA, KS, MD, MA, MI, MO, NJ, NM, NY, NC, OK, PA, TX, WA, DC
About Pentax of America Inc
Pentax of America Inc has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report