Pentax recalls

2 official recalls and safety alerts involving Pentax since 2025-03, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Pentax or the relevant agency.

  1. 2025-08-27
  2. US
    Drugs & medicalClass II

    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…

    FDA · DevicePentax of America IncUS Distribution to states of: AZ, CA, DC, FL IA, ID, IL, KS, MA, MD, MI, MO,…Official notice →
  3. 2025-03-05
  4. US
    Drugs & medicalClass II

    Pentax 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…

    FDA · DevicePentax of America IncNationwideOfficial notice →