Pentax of America recalls

Pentax of America has 38 recalls on record with the FDA and USDA, the earliest in 2016 and the latest reported on 4 Nov 2026. 11 are still ongoing. 5 were reported in the last 12 months.

Total recalls38since 2016

Last 12 months5reported

Class I00% of total

Ongoing11latest 4 Nov 2026

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 3Mar 0 0 0Jun 0 1 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 5

Severity split

Class I 0 0%Class II 38 100%Class III 0 0%

Why pentax of america is recalled

Product types

By year

2026513%
2025411%
202138%
2020411%
2019411%
201838%
20171129%
2016411%

Ongoing pentax of america recalls

11 active

Reported	Class	Recall	Company	Reason	Where
4 Nov 2026Device	CLASS II	Pentax Medical Ultrasound Endoscope recalled by Pentax of America	Pentax of America	Sterility	Nationwide
4 Nov 2026Device	CLASS II	Pentax Medical Ultrasound Endoscope recalled by Pentax of America	Pentax of America	Sterility	Nationwide
4 Nov 2026Device	CLASS II	Pentax Medical Ultrasound Endoscope recalled by Pentax of America	Pentax of America	Sterility	Nationwide
4 Nov 2026Device	CLASS II	Pentax Medical Water bottle assembly recalled by Pentax of America	Pentax of America	Sterility	Nationwide
4 Nov 2026Device	CLASS II	Pentax Medical Ultrasound Endoscope recalled by Pentax of America	Pentax of America	Sterility	Nationwide
27 Aug 2025Device	CLASS II	Pentax Medical Video Processor recalled by Pentax of America	Pentax of America	Other	20 states

All pentax of america recalls, newest first

38 total

Reported	Class	Recall	Company	Reason	Where
4 Nov 2026Device	CLASS II	Pentax Medical Ultrasound Endoscope recalled by Pentax of America	Pentax of America	Sterility	Nationwide
4 Nov 2026Device	CLASS II	Pentax Medical Ultrasound Endoscope recalled by Pentax of America	Pentax of America	Sterility	Nationwide
4 Nov 2026Device	CLASS II	Pentax Medical Ultrasound Endoscope recalled by Pentax of America	Pentax of America	Sterility	Nationwide
4 Nov 2026Device	CLASS II	Pentax Medical Water bottle assembly recalled by Pentax of America	Pentax of America	Sterility	Nationwide
4 Nov 2026Device	CLASS II	Pentax Medical Ultrasound Endoscope recalled by Pentax of America	Pentax of America	Sterility	Nationwide
27 Aug 2025Device	CLASS II	Pentax Medical Video Processor recalled by Pentax of America	Pentax of America	Other	20 states
5 Mar 2025Device	CLASS II	Pentax Medical Video Colonoscope- Intended to provide recalled	Pentax of America	Other	Nationwide
5 Mar 2025Device	CLASS II	Pentax Medical Video Upper GI Scope-Intended to provide recalled	Pentax of America	Other	Nationwide
5 Mar 2025Device	CLASS II	Pentax Medical Video Processor- Intended to be used recalled	Pentax of America	Other	Nationwide
22 Sep 2021Device	CLASS II	Colonoscope Family # 1-Pentax Video Colonoscopes recalled	Pentax of America	Other	Nationwide
22 Sep 2021Device	CLASS II	Gastroscope Family # 1-Gastroscopes without a Water Jet Channel recalled	Pentax of America	Other	Nationwide
2 Jun 2021Device	CLASS II	Pentax Medical Video Duodenoscope recalled by Pentax of America	Pentax of America	Other	Nationwide
4 Nov 2020Device	CLASS II	9310HD Digital Video Capture Module recalled by Pentax of America	Pentax of America	Device Malfunction	Nationwide
4 Nov 2020Device	CLASS II	9372HD Digital Capture (ver recalled by Pentax of America	Pentax of America	Device Malfunction	Nationwide
26 Feb 2020Device	CLASS II	Pentax Video Colonoscope recalled by Pentax of America	Pentax of America	Other	MA, NC
26 Feb 2020Device	CLASS II	Pentax Video Colonoscope recalled by Pentax of America	Pentax of America	Other	MA, NC
22 May 2019Device	CLASS II	Pentax Medical C2 CryoBalloon Standard 90 degree Catheter recalled	Pentax of America	Foreign Material	17 states
22 May 2019Device	CLASS II	Pentax Medical C2 CryoBalloon Pear Focal Catheter recalled	Pentax of America	Foreign Material	17 states
22 May 2019Device	CLASS II	Pentax Medical C2 CryoBalloon Standard Focal Catheter recalled	Pentax of America	Foreign Material	17 states
13 Mar 2019Device	CLASS II	C2 CryoBalloon Controller recalled by PENTAX of America	Pentax of America	Device Malfunction	Nationwide
27 Jun 2018Device	CLASS II	C2 CryoBalloon Focal Catheter recalled by PENTAX of America	Pentax of America	Other	Nationwide
28 Feb 2018Device	CLASS II	Pentax Video Duodenoscope recalled by Pentax of America	Pentax of America	Processing Deviation	Nationwide
21 Feb 2018Device	CLASS II	Video Cystoscope recalled by Pentax of America	Pentax of America	Other	8 states
30 Aug 2017Device	CLASS II	Ultrasound Video Gastroscope recalled by Pentax of America	Pentax of America	Other	Nationwide
30 Aug 2017Device	CLASS II	Ultrasound Video Gastroscope recalled by Pentax of America	Pentax of America	Other	Nationwide
26 Jul 2017Device	CLASS II	9310HD Digital Video Capture Modules recalled by Pentax of America	Pentax of America	Other	Nationwide
26 Jul 2017Device	CLASS II	7245C, 7245C/E, 7245D Computer Digital Video System recalled	Pentax of America	Other	Nationwide
26 Jul 2017Device	CLASS II	9200C and 9200D Laryngeal Strobe recalled by Pentax of America	Pentax of America	Other	Nationwide
26 Jul 2017Device	CLASS II	9400 Laryngeal Strobe recalled by Pentax of America	Pentax of America	Other	Nationwide
19 Jul 2017Device	CLASS II	Video Duodenoscope These instruments are intended recalled	Pentax of America	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.