Pentax of America Inc
24 recalls on record · Latest: Aug 27, 2025
FDA Devices Moderate Aug 27, 2025
Pentax Medical Video Processor; Model Number: EPK-i8020c;
FDA Devices Moderate Mar 5, 2025
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, t…
FDA Devices Moderate Mar 5, 2025
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastroint…
FDA Devices Moderate Mar 5, 2025
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointe…
FDA Devices Moderate Sep 22, 2021
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gas…
FDA Devices Moderate Sep 22, 2021
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-38…
FDA Devices Moderate Jun 2, 2021
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visua…
FDA Devices Moderate Nov 4, 2020
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
FDA Devices Moderate May 22, 2019
Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended …
FDA Devices Moderate May 22, 2019
Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to b…
FDA Devices Moderate May 22, 2019
Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is inten…
FDA Devices Moderate Mar 13, 2019
C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosur…
FDA Devices Moderate Jun 27, 2018
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifica…
FDA Devices Moderate Feb 28, 2018
Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical visu…
FDA Devices Moderate Feb 21, 2018
Video Cystoscope models ECY-1570 and ECY-1570K
FDA Devices Moderate Aug 30, 2017
Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitac…
FDA Devices Moderate Jul 26, 2017
9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal o…
FDA Devices Moderate Jul 26, 2017
9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of …
FDA Devices Moderate Jul 26, 2017
7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, tran…
FDA Devices Moderate Jul 19, 2017
Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliar…
FDA Devices Moderate Jun 21, 2017
Video Cytoscopes
FDA Devices Moderate Dec 21, 2016
Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualizati…
FDA Devices Moderate Nov 30, 2016
Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy…
FDA Devices Moderate Nov 2, 2016