Reported Sep 22, 2021 · Ongoing
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models
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?
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models
3 of 3 products
| # | Product as published |
|---|---|
| 1 | EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10 |
| 2 | Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10 |
| 3 | Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK |
- Lot codes and dates
- All devices distributed by Pentax in the US between April 2014 and May 2021
- Amount recalled
- 28849 units Total
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
- Nationwide
Why it was recalled
Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
This product could cause temporary or reversible health problems — stop using it.
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