Pentax of America Inc: Medical Device Recall in 2017 - (Recall #: Z-2713-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Video Duodenoscope 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.

Product Classification:

Class II

Date Initiated: January 17, 2017

Date Posted: July 19, 2017

Recall Number: Z-2713-2017

Event ID: 77308

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2,015 (US - 519 (ED-3490TK) and 5 (ED-3270K); OUS - 1,491)

Code Information:

Model Numbers: Ed-3490TK and ED-3270K

Distribution Pattern:

Worldwide Distribution-US (Nationwide) including states of: AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, UT, VA, WA, WI, WV, WY;. and country of: CANADA.

Voluntary or Mandated:

Voluntary: Firm initiated