Pentax of America Inc: Device Recall
Recall #Z-2329-2025 · 07/16/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2329-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Pentax of America Inc
- Status
- Ongoing
- Date Initiated
- 07/16/2025
- Location
- Montvale, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 144 units
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.
Product Description
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Distribution Pattern
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.
Other Recalls by Pentax of America Inc
- Class II: Risk 01/29/2025
- Class II: Risk 01/29/2025
- Class II: Risk 01/29/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.