Pentax Medical recalls

Pentax Medical has 26 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 3 Aug 2016.

Total recalls26since 2013

Last 12 months0reported

Class I14% of total

Ongoing0latest 3 Aug 2016

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 4%Class II 25 96%Class III 0 0%

Why pentax medical is recalled

Other Reasons2596%
Device Malfunction14%

Product types

By year

20162388%
201428%
201314%

All pentax medical recalls, newest first

26 total

Reported	Class	Recall	Company	Reason	Where
3 Aug 2016Device	CLASS II	Confocal GI Scope recalled by Pentax Medical	Pentax Medical	Other	Nationwide
3 Aug 2016Device	CLASS II	Duodenoscope Product Usage: Intended to provide optical recalled	Pentax Medical	Other	Nationwide
3 Aug 2016Device	CLASS II	Gastroscope Product Usage: Intended to provide optical visualization recalled	Pentax Medical	Other	Nationwide
3 Aug 2016Device	CLASS II	Ultrasound Gastroscope recalled by Pentax Medical	Pentax Medical	Other	Nationwide
3 Aug 2016Device	CLASS II	Colonoscope Product Usage: Intended to provide optical visualization recalled	Pentax Medical	Other	Nationwide
3 Aug 2016Device	CLASS II	Signmoidoscope Product Usage: Intended to provide optical recalled	Pentax Medical	Other	Nationwide
6 Jul 2016Device	CLASS II	Naso-Pharyngo-Laryngoscope Intended to provide optical recalled	Pentax Medical	Other	Nationwide
6 Jul 2016Device	CLASS II	Gastroscope Intended to provide optical visualization recalled	Pentax Medical	Other	Nationwide
6 Jul 2016Device	CLASS II	Choledochoscope Intended to provide optical visualization recalled	Pentax Medical	Other	Nationwide
6 Jul 2016Device	CLASS II	Confocal GI Scope Intended to provide optical visualization recalled	Pentax Medical	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.