Reported Aug 27, 2025 · Ongoing
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Pentax of America Inc
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pentax of America Inc · 3 Paragon Dr · Montvale, NJ · 07645-1782
Is this the product you have?
- Pentax Medical Video Processor
- Model NumberEPK-i8020c
- Lot codes and dates
- Model NumberEPK-i8020c
- UDI-DI04961333247974
- Serial Numbers
144 of 144 codes
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
- Amount recalled
- 144 units
Where it was sold
Why it was recalled
During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. 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 membrane.
This product could cause temporary or reversible health problems — stop using it.
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