Pentax of America Inc
Complete recall history across all FDA and CPSC categories — 33 total recalls
Pentax of America Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (33)
FDA medical device enforcement actions by Pentax of America Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Jul 16, 2025 | Pentax Medical Video Processor; Model Number: EPK-i8020c; | During endoscopic procedures using a combination of the video processor EPK-i... | Class II |
| Jan 29, 2025 | PENTAX Medical Video Colonoscope- Intended to provide optical visualization ... | During endoscopic procedures using a combination of the video processor EPK-i... | Class II |
| Jan 29, 2025 | PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization... | During endoscopic procedures using a combination of the video processor EPK-i... | Class II |
| Jan 29, 2025 | Pentax Medical Video Processor- Intended to be used with PENTAX Medical endos... | During endoscopic procedures using a combination of the video processor EPK-i... | Class II |
| Jul 14, 2021 | Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrum... | Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Vide... | Class II |
| Jul 14, 2021 | Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-27... | Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Vide... | Class II |
| Apr 21, 2021 | Pentax Medical Video Duodenoscope - Product Usage: intended to be used with e... | IFU updated: The warning section of the IFU for both the OE-A63 distal end ca... | Class II |
| Sep 22, 2020 | 9310HD Digital Video Capture Module with software version 3.4.0 or higher con... | There is an intermittent software issue that could affect the systems, in whi... | Class II |
| Sep 22, 2020 | 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), | There is an intermittent software issue that could affect the systems, in whi... | Class II |
| Jan 3, 2020 | Pentax Video Colonoscope Model: EC34-i10L | Distributed in the USA without an approved 510K | Class II |
| Jan 3, 2020 | Pentax Video Colonoscope Model: EC38-i10L | Distributed in the USA without an approved 510K | Class II |
| Dec 3, 2018 | Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Ste... | Incorrect default dose and dose increments may be transmitted to the controll... | Class II |
| Dec 3, 2018 | Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX... | Incorrect default dose and dose increments may be transmitted to the controll... | Class II |
| Dec 3, 2018 | C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 ... | The Controller does not detect overpressure in the balloon during the applica... | Class II |
| Dec 3, 2018 | Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile... | Incorrect default dose and dose increments may be transmitted to the controll... | Class II |
| Mar 30, 2018 | C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System i... | The catheter alignment arrow printed onto the strain relief is not aligned wi... | Class II |
| Feb 13, 2018 | Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 049... | The duodenoscopes are being recalled in order to replace the forceps elevator... | Class II |
| Jul 13, 2017 | Video Cystoscope models ECY-1570 and ECY-1570K | The video cytoscopes lack 510(k) premarket notification clearance. | Class II |
| May 23, 2017 | Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to... | Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used w... | Class II |
| May 23, 2017 | Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended t... | Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used w... | Class II |
| Apr 13, 2017 | 9310HD Digital Video Capture Modules Product Usage: The 9310HD is used t... | Pentax Medical did not always provide transformers with 9175 isolation transf... | Class II |
| Apr 13, 2017 | 7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7... | Pentax Medical did not always provide transformers with 9175 isolation transf... | Class II |
| Apr 13, 2017 | 9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to el... | Pentax Medical did not always provide transformers with 9175 isolation transf... | Class II |
| Apr 13, 2017 | 9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronicall... | Pentax Medical did not always provide transformers with 9175 isolation transf... | Class II |
| Jan 17, 2017 | Video Duodenoscope These instruments are intended to provide optical visua... | Pentax initiated a field correction/safety alert for two (2) models of the ... | Class II |
| Dec 12, 2016 | Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9... | Pentax is initiating a Field Correction to revise the Instructions for Use of... | Class II |
| Aug 15, 2016 | Pentax Video Colonoscope is intended to be used with a PENTAX video processor... | Pentax is initiating the product correction of several model numbers of Penta... | Class II |
| Aug 15, 2016 | Pentax Video Gastroscope is intended to be used with a Pentax video processor... | PENTAX Medical is initiating this field action to provide customers that have... | Class II |
| May 31, 2016 | Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor... | Pentax America Inc. is recalling various bronchoscopes which contain an incor... | Class II |
| May 31, 2016 | Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope,... | The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance da... | Class II |
| Jan 11, 2011 | Video Naso pharyngo Laryngoscopes | This field action serves to retrospectively document the actions that were ta... | Class II |
| Jan 11, 2011 | Video Bronchoscope | This field action serves to retrospectively document the actions that were ta... | Class II |
| Jan 11, 2011 | Video Cytoscopes | This field action serves to retrospectively document the actions that were ta... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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