FDA (Devices) recall action 77310
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
Pentax of America Inc. is recalling Video Cytoscopes to correct loose suction arms. This action retrospectively documents corrections made in 2010-2011.
Pentax of America Inc is recalling 1,701 video bronchoscopes due to loose suction arms. The action retrospectively documents corrections made in 2010-2011.
Pentax of America Inc is recalling 1,701 Video Nasopharyngolaryngoscopes due to loose suction arms. The action documents corrective measures taken in 2010-2011.