Pentax of America Inc
33 recalls on record · Latest: Aug 27, 2025
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Agency notice ledger
Federal filing book Pentax of America Inc MID-BOOK · SINGLE-AGENCY
#512 of 14,151 · 33 notices · 0.032% archive
- BOOK 33 notices
- RANK #512 of 14,151
- SHARE 0.032% archive
- AGENCY FDA Devices (33)
- CAT medical devices
- CATS 1 category
- LATEST Aug 27, 2025
- PHOTO Avkare Inc.
Nearest notice-volume peer: Avkare Inc. (0 notice gap)
Pentax of America Inc accounts for about 0.032% of the 104,423-notice archive on 33 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →
Where Pentax of America Inc sits among 14,151 recalling firms
Pentax of America Inc ranks 512th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
Pentax of America Inc vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
33 512th of 14151 higher than 13,632 of 14,151 firms
Firms, banded by distinct federal recall-event inventory
Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13
Pentax of America Inc in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
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What this shows Pentax of America Inc holds about 0.032% of archive notices alongside 33 distinct filings.
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, treatment, and video observation. Model: EPK-i8020c
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 gastrointestinal tract Model: EG29-i20c
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 gastrointestinal tract Model: EC38-i20cL
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- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK
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-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK
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 visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.
FDA Devices Moderate Nov 4, 2020
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
FDA Devices Moderate Nov 4, 2020
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
FDA Devices Moderate Feb 26, 2020
Pentax Video Colonoscope Model: EC38-i10L
FDA Devices Moderate Feb 26, 2020
Pentax Video Colonoscope Model: EC34-i10L
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 to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablat
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 be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation
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 intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and a
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 cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus.
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, specifically for endoscopic applications.
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 visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic, and cystic ducts.
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 Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
FDA Devices Moderate Aug 30, 2017
Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
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 or pharyngeal structures, and audio data, for medical and pedagogical applications.
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 laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
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, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.
FDA Devices Moderate Jul 26, 2017
9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
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 biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.
FDA Devices Moderate Jun 21, 2017
Video Cytoscopes
FDA Devices Moderate Jun 21, 2017
Video Bronchoscope
FDA Devices Moderate Jun 21, 2017
Video Naso pharyngo Laryngoscopes
FDA Devices Moderate Feb 1, 2017
Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
FDA Devices Moderate Dec 21, 2016
Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in
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 Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
FDA Devices Moderate Nov 2, 2016
Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach and duodenum.
FDA Devices Moderate Sep 28, 2016
Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Pentax of America Inc holds a measurable archive slice
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (33 here).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name Pentax of America Inc? ▼
PlainRecalls indexes 33 distinct federal recall events naming Pentax of America Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Pentax of America Inc sit among other recalling firms? ▼
Pentax of America Inc ranks #512 of 14,151 by distinct recall-event count among 14,151 firms in this archive (96th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Pentax of America Inc's notices? ▼
FDA Devices accounts for 33 of this firm's 33 indexed notices.
What product category dominates Pentax of America Inc's filing book? ▼
Filings for Pentax of America Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Pentax of America Inc: 33 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.
Firm-level totals aggregate distinct federal recall events naming Pentax of America Inc; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026