Pentax of America Inc: Medical Device Recalls in 2018

Updated on March 25, 2026.

According to to data from the FDA, there were 2 medical device recalls made by Pentax of America Inc in 2018. See the details of the recalls below.

You can see similar recalls for other firms.

Data Source: FDA.

See this for other years:

Video Cystoscope models ECY-1570 and ECY-1570K
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 biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic, and cystic ducts.