Z-2325-2017Class II

Video Cytoscopes

Name: Z-2325-2017 Video Cytoscopes
Creator: Pentax of America Inc
Published: 2011-01-11
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2011-01-11 / Terminated / root cause: design

FDA source

Pentax of America Inc began a recall of Video Cytoscopes on 2011-01-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2325-2017
Classification: Class II
Status: Terminated
Initiated: 2011-01-11
Posted: 2017-06-09
Terminated: 2018-03-13
Recalling firm: PENTAX of America, Inc.
Product: Video Cytoscopes
Product code: EOQ Bronchoscope (Flexible Or Rigid)
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.
Root cause tag: design
FDA root cause: Device Design
Action: Customers were visited by members of Pentax America, Inc. field service team. The field service technicians inspected the affected devices, and documented the inspections using the Inspection Record Form (QS-397).
Quantity in commerce: 1,349 - (Total - US) and 352 (Total - OUS)
Distribution: US Nationwide and Internationally
Product codes and lots: Model #'s:ECY-1570 and ECY-1570K

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2325-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2324-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-09
Z-2325-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-09
Z-2326-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-09

Product code EOQ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)