Pentax Of America Inc
Redwood City, CA
This page shows every FDA and USDA recall linked to Pentax Of America Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
5
Total Recalls
2018
First Recall
2018
Most Recent
C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258
The C2 CryoBalloon Ablation Syste...
Dec 3, 2018
· Device
Terminated
Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX.
Product Usage:
The C2 Cryo...
Dec 3, 2018
· Device
Terminated
Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX.
Product Usage:
The C2...
Dec 3, 2018
· Device
Terminated
Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX.
Product Usage:
The C2 CryoBall...
Dec 3, 2018
· Device
Terminated
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in...
Jun 5, 2018
· Device
Terminated