Reported Mar 5, 2025 · Ongoing
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic…
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 Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to
- the lower gastrointestinal tract ModelEG29-i20c
- Lot codes and dates
- UDI04961333252145
- Serial Numbers
138 of 138 codes
A0038A0431A0038A0433A0038A0435A0038A0447A0038A0451A0038A0452A0038A0454A0038A0458A0038A0460A0038A0474A0038A0475A0038A0479A0038A0486A0038A0488A0038A0489A0038A0492A0038A0494A0038A0496A0038A0497A0038A0500A0038A0502A0038A0503A0038A0507A0038A0513A0038A0514A0038A0516A0038A0527A0038A0529A0038A0536A0038A0538A0038A0539A0038A0541A0038A0557A0038A0558A0038A0560A0038A0563A0038A0566A0038A0568A0038A0570A0038A0573A0038A0574A0038A0575A0038A0577A0038A0579A0038A0583A0038A0584A0038A0585A0038A0594A0038A0595A0038A0596A0038A0597A0038A0598A0038A0599A0038A0600A0038A0601A0038A0602A0038A0605A0038A0606A0038A0607A0038A0608
- Amount recalled
- 138 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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