Pentax of America Inc: Device Recall
Recall #Z-1238-2025 · 01/29/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1238-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Pentax of America Inc
- Status
- Ongoing
- Date Initiated
- 01/29/2025
- Location
- Montvale, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 94 units
Reason for Recall
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 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 membranes.
Product Description
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c
Distribution Pattern
Nationwide
Other Recalls by Pentax of America Inc
- Class II: Risk 07/16/2025
- 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.