Reported Mar 5, 2025 · Ongoing
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral…
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- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation
- ModelEPK-i8020c
- Lot codes and dates
- UDI04961333247974
- Serial Numbers
94 of 94 codes
B0023Z1193B0023Z1195B0023Z1245B0023Z1247B0023Z1250B0023Z1255B0023Z1256B0023Z1276B0023Z1277B0023Z1279B0023Z1280B0023Z1286B0023Z1290B0023Z1296B0023Z1313B0023Z1335B0023Z1451B0023Z1461B0023Z1478B0023Z1481B0023Z1565B0023Z1573B0023Z1628B0023Z1631B0023Z1637B0023Z1639B0023Z1645B0023Z1648B0023Z1652B0023Z1653B0023Z1655B0023Z1656B0023Z1659B0023Z1661B0023Z1665B0023Z1667B0023Z1669B0023Z1671B0023Z1676B0023Z1678B0023Z1682B0023Z1694B0023Z1696B0023Z1698B0023Z1711B0023Z1712B0023Z1716B0023Z1717B0023Z1732C0023Z0021C0023Z0072C0023Z0074C0023Z0078C0023Z0082C0023Z0084C0023Z0085C0023Z0087C0023Z0091C0023Z0092C0023Z0094
- Amount recalled
- 94 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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