FDA recall Z-2325-2017

Product

Video Cytoscopes

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.

Distribution

US Nationwide and Internationally

Key facts

Status

Terminated

Initiation date

2011-01-11

Report date

2017-06-21

Termination date

2018-03-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Montvale, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2325-2017