Pentax recalls specific medical colonoscopes due to potential thermal injury from reddish images during use. Affected models include EC38-i20cL with listed serial numbers. Stop using immediately to avoid mucous membrane burns.
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 colonoscopes that may cause thermal injury to patients during procedures. The risk occurs when the video processor and endoscope combination produces reddish images and hot light guides, potentially burning the patient's mucous membranes.
The colonoscope's light guide can become hot during or after use, and may cause burns to the patient's mucous membranes. This happens when the video processor (EPK-i8020c) and i20c series endoscope produce reddish or dark images during procedures.
Patients undergoing colonoscopies using the recalled Pentax EC38-i20cL models are at risk. Medical professionals using these specific colonoscopes during procedures may cause harm if the device malfunctions.
Check for the model EC38-i20cL with serial numbers listed in the recall notice. The device is sold by Pentax of America Inc for medical use.
Discontinue use of the recalled colonoscope to prevent potential thermal injury to the patient's mucous membranes.
The affected models are Pentax EC38-i20cL with specific serial numbers listed in the recall notice.
The device may cause thermal injury to the patient's mucous membranes due to hot light guides during or after use, especially when the video processor and endoscope produce reddish images.
The recall does not provide a fix; users must stop using the device immediately.
We’ve drafted a message you can send Pentax to request your refund or repair — edit it as you like.
Subject: Recall Z-1236-2025 — Pentax Pentax Hello, I own a Pentax that is covered by recall Z-1236-2025 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.
