Pentax recalls specific medical endoscopes due to risk of thermal injury to mucous membranes during procedures. The device may emit hot light guides and cause reddish/dark images. Affected models include EG29-i20c with listed serial numbers.
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 is recalling certain medical endoscopes that could cause thermal injury to patients' mucous membranes during use. The risk occurs when the device's light guide becomes hot, potentially leading to burns or tissue damage.
During endoscopic procedures, the video processor and endoscope combination can cause the light guide at the tip to become hot. This may result in reddish or dark images on the monitor and could lead to thermal injury to the patient's mucous membranes.
Healthcare professionals using the recalled endoscopes for upper GI procedures are most at risk. Patients undergoing these procedures with the affected equipment could experience thermal injuries.
Check for the model EG29-i20c with serial numbers listed in the recall notice. The device is sold under Pentax Medical and intended for upper GI procedures.
Immediately stop using the recalled endoscopes if you have them, as they pose a risk of thermal injury.
The recalled model is EG29-i20c with specific serial numbers listed in the recall notice.
Check if your endoscope has the model EG29-i20c and one of the listed serial numbers in the recall notice.
Immediately stop using it and contact Pentax of America Inc for further instructions.
We’ve drafted a message you can send Pentax to request your refund or repair — edit it as you like.
Subject: Recall Z-1237-2025 — Pentax Pentax Hello, I own a Pentax that is covered by recall Z-1237-2025 from Pentax. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
