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Pentax Of America Inc Recalls

23 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Pentax Of America Inc.

23Total Recalls
0Critical
71,979Units Affected
Jul 16, 2025Most Recent
All Recalls

Every Pentax Of America Inc Recall

Sorted by most recent. Click any recall for full details.

23 recalls
High RiskFDA
Pentax Of America Inc
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Medical Devices·144 affected·Jul 16, 2025
High RiskFDA
Pentax Of America Inc
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic ...
Medical Devices·94 affected·Jan 29, 2025
High RiskFDA
Pentax Of America Inc
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the low...
Medical Devices·138 affected·Jan 29, 2025
High RiskFDA
Pentax Of America Inc
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Fam...
Medical Devices·28,849 affected·Jul 14, 2021
High RiskFDA
Pentax Of America Inc
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3...
Medical Devices·28,849 affected·Jul 14, 2021
High RiskFDA
Pentax Of America Inc
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide o...
Medical Devices·108 affected·Apr 21, 2021
High RiskFDA
Pentax Of America Inc
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
Medical Devices·39 affected·Sep 22, 2020
High RiskFDA
Pentax Of America Inc
Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System ...
Surgical Devices·157 affected·Dec 3, 2018
High RiskFDA
Pentax Of America Inc
C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used ...
Surgical Devices·45 affected·Dec 3, 2018
High RiskFDA
Pentax Of America Inc
Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is i...
Surgical Devices·68 affected·Dec 3, 2018
High RiskFDA
Pentax Of America Inc
Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation Sys...
Surgical Devices·4 affected·Dec 3, 2018
High RiskFDA
Pentax Of America Inc
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surger...
Surgical Devices·57 affected·Mar 30, 2018
High RiskFDA
Pentax Of America Inc
Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide ...
Medical Devices·559 affected·Feb 13, 2018
High RiskFDA
Pentax Of America Inc
Video Cystoscope models ECY-1570 and ECY-1570K
Medical Devices·24 affected·Jul 13, 2017
High RiskFDA
Pentax Of America Inc
Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit m...
Medical Devices·118 affected·May 23, 2017
High RiskFDA
Pentax Of America Inc
9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of...
Medical Devices·241 affected·Apr 13, 2017
High RiskFDA
Pentax Of America Inc
9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital vi...
Medical Devices·241 affected·Apr 13, 2017
High RiskFDA
Pentax Of America Inc
7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, d...
Medical Devices·241 affected·Apr 13, 2017
High RiskFDA
Pentax Of America Inc
Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to...
Medical Devices·2,015 affected·Jan 17, 2017
High RiskFDA
Pentax Of America Inc
Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor,...
Surgical Devices·3,436 affected·Aug 15, 2016
High RiskFDA
Pentax Of America Inc
Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor,...
Surgical Devices·5,090 affected·Aug 15, 2016
High RiskFDA
Pentax Of America Inc
Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic...
Medical Implants·113 affected·May 31, 2016
High RiskFDA
Pentax Of America Inc
Video Cytoscopes
Medical Devices·1,349 affected·Jan 11, 2011