Official recall record
Pentax Medical Video Processor
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-08-07
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Under certain conditions 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. While we have not received reports of any serious incidents, some have observed steam-like vaporization and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, which may pose a risk to patients. Recall start date: August 4, 2025
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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