Pentax Medical Company

FDA recalling firm · 6 enforcement events · 26 product records · 2013–2016 · NJ

Pentax Medical Company has 6 FDA enforcement events on this register (26 product records) between 2013 and 2016: 6 device; the busiest year was 2016 with 3.

17% of its events are Class I; the most common class is Class II (5). 0 events are listed as ongoing; the recalling firm's address is in NJ.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
6 Apr 2016	Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent…	Device	Class II	6	Terminated
6 Apr 2016	Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Nasal Passage, Trachea and Bronchial Tree. The instrument is introduced via the mouth or the nose, as decided by the…	Device	Class II	16	Terminated
22 Feb 2016	Video Duodenoscope	Device	Class II	1	Terminated
17 Jul 2014	PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve	Device	Class II	1	Terminated
12 Jun 2014	EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.	Device	Class II	1	Terminated
16 Sep 2013	PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.	Device	Class I	1	Terminated

By type and class

Device6

Class II5

Class I1

Class I: 17% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Pentax Medical Company by year initiated.

Questions and answers

How many FDA recalls has Pentax Medical Company had?

6 enforcement events (26 product records) on this register, 2013–2016: 6 device.

Are any Pentax Medical Company recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Pentax Medical Company recalls?

5 Class II, 1 Class I. 17% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.