Pentax Of America Inc recalls PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a…

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.

Pentax issued URGENT i20c Endoscope User Notification-Precautions when using PENTAX Medical i20c endoscopes with EPK-i8020c Processor Letter on 1/29/25 certified USPS Mail. The letter states reason for recall, health risk and action to take: Customer Instructions: Perform a pre-use inspection according to the Instructions for Use to make sure that there are no foreign objects, scratches, chips, or other abnormalities on the light guide. Do not use OE (Optical Enhancement) mode in cases where there is bleeding such as hematemesis or hematochezia, or where a lot of bleeding was observed during an endoscopic examination or procedure. Use normal observation mode and set the illumination brightness to the minimum necessary. If you notice any abnormalities, such as the observed image being reddish or darker than normal, discontinue use and immediately remove the endoscope from the patient while keeping the endoscope at a distance from the mucous membrane. The temperature at the tip of the endoscope could rise and may cause thermal injury to the patient's mucous membranes. After removing the endoscope, turn off the video processor lamp. Check the distal end of the endoscope, remove any attached patient material, and confirm that the light guide is normal before using it again. If you cannot completely remove all patient material from the distal end of the endoscope, discontinue use and contact PENTAX Medical service facility and request repairs. Please download the Instructions for use (IFU) from the PENTAX Medical online IFU library at https://ifu.pentaxmedical.com for the following products: Models EPK-i8020c; EC38-i20cL; EG29-i20c. Further Actions by PENTAX Medical: PENTAX Medical is currently considering countermeasures that will help to further reduce the potential risks mentioned above. PENTAX Medical will duly notify you when we are ready to implement the changes. Contact Information: Please indicate through the attached response form that you have received and

• FDA enforcement recordOfficial FDA database entry for Z-1236-2025
• FDA 510(k) clearance · K231249The device's official FDA premarket clearance record
• FDA device classification · PEAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.1500The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Pentax of America IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.