Pentax recalls
Pentax appears in 33 official U.S. recall notices indexed by RecallRadar, most recently on 2025-08-27.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Pentax Medical Video Processor
FDA Device · Class II · 2025-08-27 · Pentax - PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower g…
FDA Device · Class II · 2025-03-05 · Pentax - Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic di…
FDA Device · Class II · 2025-03-05 · Pentax - PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower…
FDA Device · Class II · 2025-03-05 · Pentax - Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10
FDA Device · Class II · 2021-09-22 · Pentax - Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490…
FDA Device · Class II · 2021-09-22 · Pentax - Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide opt…
FDA Device · Class II · 2021-06-02 · Pentax - 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
FDA Device · Class II · 2020-11-04 · Pentax - 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal)
FDA Device · Class II · 2020-11-04 · Pentax - Pentax Video Colonoscope Model: EC34-i10L
FDA Device · Class II · 2020-02-26 · Pentax - Pentax Video Colonoscope Model: EC38-i10L
FDA Device · Class II · 2020-02-26 · Pentax - Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is int…
FDA Device · Class II · 2019-05-22 · Pentax - Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is…
FDA Device · Class II · 2019-05-22 · Pentax - Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intende…
FDA Device · Class II · 2019-05-22 · Pentax - C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a…
FDA Device · Class II · 2019-03-13 · Pentax - C2 CryoBalloon Focal Catheter, REF FG-1009
FDA Device · Class II · 2018-06-27 · Pentax - Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical…
FDA Device · Class II · 2018-02-28 · Pentax - Video Cystoscope models ECY-1570 and ECY-1570K
FDA Device · Class II · 2018-02-21 · Pentax - Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by…
FDA Device · Class II · 2017-08-30 · Pentax - Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by…
FDA Device · Class II · 2017-08-30 · Pentax - 7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display,…
FDA Device · Class II · 2017-07-26 · Pentax - 9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video…
FDA Device · Class II · 2017-07-26 · Pentax - 9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryng…
FDA Device · Class II · 2017-07-26 · Pentax - 9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video dat…
FDA Device · Class II · 2017-07-26 · Pentax - Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the…
FDA Device · Class II · 2017-07-19 · Pentax - Video Bronchoscope
FDA Device · Class II · 2017-06-21 · Pentax - Video Naso pharyngo Laryngoscopes
FDA Device · Class II · 2017-06-21 · Pentax - Video Cytoscopes
FDA Device · Class II · 2017-06-21 · Pentax - Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stro…
FDA Device · Class II · 2017-02-01 · Pentax - Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic vis…
FDA Device · Class II · 2016-12-21 · Pentax - Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, E…
FDA Device · Class II · 2016-11-30 · Pentax - Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, E…
FDA Device · Class II · 2016-11-02 · Pentax - Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monito…
FDA Device · Class II · 2016-09-28 · Pentax