PlainRecalls

Pentax of America Inc

Compiled from official public sources by the editorial team.

33 recalls on record · Latest: Aug 27, 2025

Pentax of America Inc Recall Insight

Pentax of America Inc appears on 33 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.032% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Aug 27, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 33 entries, severity tagging shows 0 critical, 33 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 32 of 33 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (33). The date window on this page runs from Sep 28, 2016 to Aug 27, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

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 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 …

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 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 Hitach…

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 26, 2017

9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data…

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 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 stroboscopi…

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

Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy…

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-…

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Compare Pentax of America Inc with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.