Reported Mar 5, 2025 · Ongoing
PENTAX Medical Video Colonoscope- 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 Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to
- the lower gastrointestinal tract ModelEC38-i20cL
- Lot codes and dates
- UDI04961333252169
- Serial Numbers
152 of 152 codes
A002FA0230A002FA0244A002FA0246A002FA0247A002FA0248A002FA0259A002FA0269A002FA0271A002FA0272A002FA0274A002FA0275A002FA0278A002FA0281A002FA0282A002FA0283A002FA0293A002FA0294A002FA0299A002FA0300A002FA0301A002FA0303A002FA0304A002FA0306A002FA0307A002FA0311A002FA0314A002FA0315A002FA0316A002FA0321A002FA0324A002FA0364A002FA0371A002FA0372A002FA0376A002FA0378A002FA0381A002FA0383A002FA0384A002FA0388A002FA0390A002FA0399A002FA0408A002FA0415A002FA0418A002FA0419A002FA0420A002FA0422A002FA0423A002FA0424A002FA0428A002FA0432A002FA0433A002FA0435A002FA0436A002FA0437A002FA0438A002FA0439A002FA0440A002FA0443A002FA0445
- Amount recalled
- 152 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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