Reported Feb 21, 2018 · Terminated
Video Cystoscope models ECY-1570 and ECY-1570K
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?
- Video Cystoscope models ECY-1570 and ECY-1570K
- Lot codes and dates
- Serial number
J110097J110101G110053G110051G110052G110054G110015G110084H110086H110088J110062G110016G110039G110048G110049G110038J110061G110021J110078G110056G110057G110073G110037G110058
- Serial number
- Amount recalled
- 24
Where it was sold
Why it was recalled
The video cytoscopes lack 510(k) premarket notification clearance.
This product could cause temporary or reversible health problems — stop using it.
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