FDAFDA · Food and drugs·Recall number Z-2325-2017
Video Cytoscopes
Published June 21, 2017 · Recall initiated: January 11, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Pentax of America Inc
- Distributor
- US Nationwide and Internationally
- Lot
- Model #'s:ECY-1570 and ECY-1570K
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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