Pentax of America Inc: Medical Device Recall in 2017 - (Recall #: Z-2325-2017)

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 Cytoscopes

Product Classification:

Class II

Date Initiated: January 11, 2011

Date Posted: June 21, 2017

Recall Number: Z-2325-2017

Event ID: 77310

Reason for Recall:

This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.

Status: Terminated

Product Quantity: 1,349 - (Total - US) and 352 (Total - OUS)

Code Information:

Model #'s:ECY-1570 and ECY-1570K

Distribution Pattern:

US Nationwide and Internationally

Voluntary or Mandated:

Voluntary: Firm initiated