Pentax Of America Inc
Montvale, NJ
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.
28
Total Recalls
2011
First Recall
2025
Most Recent
Pentax Medical Video Processor;
Model Number: EPK-i8020c;
Aug 15, 2025
· Device
Open, Classified
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and the...
Feb 26, 2025
· Device
Open, Classified
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and th...
Feb 26, 2025
· Device
Open, Classified
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other periphe...
Feb 26, 2025
· Device
Open, Classified
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel
Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K...
Jul 14, 2021
· Device
Open, Classified
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Chann...
Jul 14, 2021
· Device
Open, Classified
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancil...
Apr 21, 2021
· Device
Terminated
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
Oct 23, 2020
· Device
Terminated
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
Oct 23, 2020
· Device
Terminated
Pentax Video Colonoscope
Model: EC38-i10L
Jan 3, 2020
· Device
Terminated
Pentax Video Colonoscope
Model: EC34-i10L
Jan 3, 2020
· Device
Terminated
Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420)
These instruments...
Feb 20, 2018
· Device
Terminated
Video Cystoscope models ECY-1570 and ECY-1570K
Jul 13, 2017
· Device
Terminated
Ultrasound Video Gastroscope, Model EG-3670URK,
The product is intended to be used in combination with the u...
May 23, 2017
· Device
Terminated
Ultrasound Video Gastroscope, Model EG-3870UTK.
The product is intended to be used in combination with the ul...
May 23, 2017
· Device
Terminated
9200C and 9200D
Laryngeal Strobe
Product Usage:
The 9310HD is used to electronically record, display, transfe...
Apr 13, 2017
· Device
Terminated
9400
Laryngeal Strobe
Product Usage:
The 9310HD is used to electronically record, display, transfer, and stor...
Apr 13, 2017
· Device
Terminated
9310HD
Digital Video Capture Modules
Product Usage:
The 9310HD is used to electronically record, display, tra...
Apr 13, 2017
· Device
Terminated
7245C, 7245C/E, 7245D
Computer Digital Video System
Product Usage:
The 7245C, 7245C/E and 7245D are used to e...
Apr 13, 2017
· Device
Terminated
Video Duodenoscope
These instruments are intended to provide optical visualization of (via a video monitor),...
Jan 17, 2017
· Device
Terminated
Rigid Laryngostroboscopes
The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic...
Dec 12, 2016
· Device
Terminated
Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), docume...
Nov 19, 2016
· Device
Terminated
Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), docume...
Oct 26, 2016
· Device
Terminated
Ultrasound Video Bronchoscope
The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical vi...
May 31, 2016
· Device
Terminated
Pentax Video Bronchoscope
Designed to be used with a Pentax Video Processor (including light source), documen...
May 31, 2016
· Device
Terminated
Video Bronchoscope
Jan 11, 2011
· Device
Terminated
Video Naso pharyngo Laryngoscopes
Jan 11, 2011
· Device
Terminated
Video Cytoscopes
Jan 11, 2011
· Device
Terminated