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PENTAX of America, Inc.

United States·US-MF-000008135

Last updated September 17, 2026

Information

Country: United States
Address: 3, Paragon Drive, Montvale, United States
Website: pentaxmedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Paresh Patel
EUDAMED SRN: US-MF-000008135
FDA FEI Number: 1000080301
DUNS Number: —

Catalogue (368)

Page 5 of 8

Device	Model / Reference	Registries	Class	Status
Irrigator/Insufflator	100551P	FDA UDI	Class II	Unknown
Extron	68404	FDA UDI	Class I	Active
Phonatory Aerodynamic System	6600	FDA UDI	Class II	Active
Video Duodenoscope	ED34-I10T	FDA UDI	Class II	Active
Nds	NDS26LED	FDA UDI	Class I	Active
Phonatory Aerodynamic System	6610	EUDAMEDFDA UDI	Class II	Active
C2 CryoBalloon	FG-1056	FDA UDI	Class II	Active
Shure	0260-0018	FDA UDI	Class II	Active
Video Colonoscope	EC34-I10L	FDA UDI	Class II	Active
Sony	UP-21MD	FDA UDI	Class I	Active
Video Processor	EPM-3500	FDA UDI	Class II	Unknown
Rigid Scopes	9109	FDA UDI	Class I	Active
Video Colonoscope	EC-3890LI	FDA UDI	Class II	Active
Dell	72067	FDA UDI	Class I	Active
Video Naso Pharyngo Laryngostroboscope	VNL-1190STK	FDA UDI	Class II	Active
Fiber Cystoscope	FCY-15RBS	FDA UDI	Class II	Active
Irrigator/Insufflator	EGA-7012	FDA UDI	Class II	Active
Defina	EPK-3000-US	FDA UDI	Class II	Active
Endoportal	9252-1	FDA UDI	Class I	Active
Sinuscope	8850	FDA UDI	Class II	Active
Extron	92169/6	FDA UDI	Class I	Active
Video Bronchoscope	EB-1575K	FDA UDI	Class II	Active
Endopro Iq	M70206	FDA UDI	Class I	Active
Endopro Iq	M70227	FDA UDI	Class I	Active
Endopro Iq	M70221-UP	FDA UDI	Class I	Active
Video Colonoscope	EC38-V10CL	FDA UDI	Class II	Active
Phonatory Aerodynamic System	6601	EUDAMEDFDA UDI	Class II	Active
Phonatory Aerodynamic System	6625	EUDAMEDFDA UDI	Class II	Active
Fiber Bronchoscope	FB-8V	FDA UDI	Class II	Active
Endopro Iq	M70223-UP	FDA UDI	Class I	Active
Video Sigmoidoscope	ES-3830K	FDA UDI	Class II	Unknown
Video Bronchoscope	EB-1970TK	FDA UDI	Class II	Active
Noblus	NOBLUS-B	FDA UDI	Class II	Active
Video Gastroscope	EG-3890TK	FDA UDI	Class II	Active
Video Colonoscope	EC-3490LK	FDA UDI	Class II	Active
Nds	NDS90Z0156	FDA UDI	Class I	Active
Fiber Bronchoscope	FB-15P	FDA UDI	Class II	Unknown
Video Colonoscope	EC38-I10L	FDA UDI	Class II	Active
Endopro Iq	M70220	FDA UDI	Class I	Active
Nds	NDS90X0660	FDA UDI	Class I	Active
Electroglottograph	6103	FDA UDI	Class II	Active
Endopro Iq	M70214-UP	FDA UDI	Class I	Active
Endopro Iq	M70228	FDA UDI	Class II	Active
Video Gastroscope	EG29-I10	FDA UDI	Class II	Active
Sinuscope	8854	FDA UDI	Class II	Active
Zutron	ZUTR10003TG	FDA UDI	Class I	Active
Endopro Iq	M70217	FDA UDI	Class I	Active
Endopro Iq	M70224-UP	FDA UDI	Class I	Active
Video Colonoscope	EC-3832L	FDA UDI	Class II	Unknown
Rigid Scopes	9108	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

PENTAX Europe GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (33)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 16, 2025	Z-2329-2025	—	open, classified	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.
Jan 29, 2025	Z-1237-2025	—	open, classified	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.
Jan 29, 2025	Z-1238-2025	—	open, classified	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.
Jan 29, 2025	Z-1236-2025	—	open, classified	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.
Jul 14, 2021	Z-2449-2021	—	open, classified	Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
Jul 14, 2021	Z-2448-2021	—	open, classified	Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
Apr 21, 2021	Z-1682-2021	—	terminated	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
Sep 22, 2020	Z-0293-2021	—	terminated	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.
Sep 22, 2020	Z-0292-2021	—	terminated	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.
Jan 3, 2020	Z-1268-2020	—	terminated	Distributed in the USA without an approved 510K
Jan 3, 2020	Z-1267-2020	—	terminated	Distributed in the USA without an approved 510K
Dec 3, 2018	Z-0970-2019	—	terminated	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.
Dec 3, 2018	Z-1326-2019	—	terminated	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.
Dec 3, 2018	Z-1325-2019	—	terminated	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.
Dec 3, 2018	Z-1327-2019	—	terminated	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.
Mar 30, 2018	Z-2256-2018	—	terminated	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.
Feb 13, 2018	Z-0643-2018	—	terminated	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.
Jul 13, 2017	Z-0615-2018	—	terminated	The video cytoscopes lack 510(k) premarket notification clearance.
May 23, 2017	Z-3068-2017	—	terminated	Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step.
May 23, 2017	Z-3067-2017	—	terminated	Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step.
Apr 13, 2017	Z-2742-2017	—	terminated	Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
Apr 13, 2017	Z-2744-2017	—	terminated	Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
Apr 13, 2017	Z-2743-2017	—	terminated	Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
Apr 13, 2017	Z-2745-2017	—	terminated	Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
Jan 17, 2017	Z-2713-2017	—	terminated	Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.
Dec 12, 2016	Z-1075-2017	—	terminated	Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.
Aug 15, 2016	Z-0318-2017	—	terminated	PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.
Aug 15, 2016	Z-0636-2017	—	terminated	Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocessing IFU's that were in use prior to the 2014 clearances and therefore did not include the cleared operation IFU, the updated reprocessing IFU or the dedicated reprocessing adaptor (for applicable models).
May 31, 2016	Z-2875-2016	—	terminated	Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.
May 31, 2016	Z-0757-2017	—	terminated	The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and September 2015 contained the Operation and Reprocessing IFUs that were in use prior to the 2014 clearance, and therefore did not include the cleared Operation and Reprocessing IFUs.
Jan 11, 2011	Z-2325-2017	—	terminated	This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.
Jan 11, 2011	Z-2326-2017	—	terminated	This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.
Jan 11, 2011	Z-2324-2017	—	terminated	This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.