Reported Feb 26, 2020 · Terminated
Pentax Video Colonoscope Model: EC34-i10L
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 Video Colonoscope ModelEC34-i10L
- Lot codes and dates
- Serial Numbers
L110300L110301L110303L110306
- Serial Numbers
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Distributed in the USA without an approved 510K
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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