Montvale, NJ, United States
Pentax of America Inc recalls
11 recalls recorded since 2018, most recently on 16 July 2025. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls11
Ongoing (FDA)3
Terminated or completed8
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 July 2025
- Reason
- During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane.
- Distribution
- US Distribution to states of: AZ, CA, DC, FL IA, ID, IL, KS, MA, MD, MI, MO, NC, NJ, NM, NY, OK, PA, TX, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2329-2025
- Pentax Medical Video Processor; Model Number: EPK-i8020c;
Ongoing Class II Medical devices
- Recall started
- 29 January 2025
- Reason
- During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1238-2025, Z-1237-2025, Z-1236-2025
- 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
- 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
- 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
Ongoing Class II Medical devices
- Recall started
- 14 July 2021
- Reason
- Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2449-2021, Z-2448-2021
- 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
- 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
Terminated Class II Medical devices
- Recall started
- 21 April 2021
- Terminated
- 5 February 2024
- Reason
- IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated risks with the distal end cap (OE-A63) unexpectedly becoming detached during a procedure and updated to notify users of what immediate actions should be taken in case the event occurs. This can result in unforseen events such as mucosal injury, lacerations, or bleeding of the patient. Detachment of the distal end cap (OE-A63) into the oral cavity of the patient may also result in aspiration
- Distribution
- US Nationwide distribution in the states of Alabama, California, Louisiana, Maryland, Michigan, Missouri, New Jersey, North Carolina, Pennsylvania, Texas, Washington, D.C.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1682-2021
- 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 T
Terminated Class II Medical devices
- Recall started
- 22 September 2020
- Terminated
- 16 May 2022
- Reason
- There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs.
- Distribution
- US Nationwide and Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0292-2021, Z-0293-2021
- 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
- 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
Terminated Class II Medical devices
- Recall started
- 3 January 2020
- Terminated
- 26 January 2021
- Reason
- Distributed in the USA without an approved 510K
- Distribution
- NC, MA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1268-2020, Z-1267-2020
- Pentax Video Colonoscope Model: EC38-i10L
- Pentax Video Colonoscope Model: EC34-i10L
Terminated Class II Medical devices
- Recall started
- 3 December 2018
- Terminated
- 14 August 2020
- Reason
- Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
- Distribution
- Distribution was made to CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada, Germany, and the Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1325-2019, Z-1326-2019, Z-1327-2019
- 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, spec
- 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, specific
- 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,
Terminated Class II Medical devices
- Recall started
- 3 December 2018
- Terminated
- 21 August 2020
- Reason
- The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.
- Distribution
- Worldwide Distribution: US (nationwide) to states of:: CA, DC, FL, LA, MA, MD, MN, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA;; and countries: Canada, Germany, and Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0970-2019
- 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
Terminated Class II Medical devices
- Recall started
- 30 March 2018
- Terminated
- 28 April 2021
- Reason
- The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the controller in the detach orientation. In this orientation, the catheter is not securely attached to the controller and may be partially (~1cm) ejected from controller.
- Distribution
- Distribution US nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2256-2018
- 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.
Terminated Class II Medical devices
- Recall started
- 13 February 2018
- Terminated
- 9 October 2020
- Reason
- The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy.
- Distribution
- USA (nationwide) Distribution to the states of including Puerto Rico : AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and WY, and the District of Columbia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0643-2018
- 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 bili
Terminated Class II Medical devices
- Recall started
- 13 July 2017
- Terminated
- 22 July 2019
- Reason
- The video cytoscopes lack 510(k) premarket notification clearance.
- Distribution
- Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0615-2018
- Video Cystoscope models ECY-1570 and ECY-1570K
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.