Pentax of America Inc recalls Pentax Medical Video Processor; Model Number: EPK-i8020c;
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…
Read the official notice →- Date
- 2025-08-27
- Country
- United States
- Brand
- Pentax
- Product
- Pentax Medical Video Processor; Model Number: EPK-i8020c;
- Classification
- Class II
- Units
- US Distribution to states of: AZ, CA, DC, FL IA, ID, IL, KS, MA, MD, MI, MO,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Pentax recalls
- 2025-03-05
USPentax of America Inc recalls Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic…
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…
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