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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