CLASS II Device recall · Reported 21 Jun 2017 · FDA Enforcement Report

Video Cytoscopes recalled by Pentax of America

Pentax of America is recalling Video Cytoscopes, distributed nationwide in the US. The recall was initiated on 11 Jan 2011 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel #'s:ECY-1570 and ECY-1570K

Quantity recalled1,349 - (Total - US) and 352 (Total - OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2325-2017
FDA event ID: 77310
Recalling firm: Pentax of America, Montvale, NJ
Classification: Class II
Status: Terminated
Recall initiated: 11 Jan 2011
FDA classified: 9 Jun 2017
Reported: 21 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 Jan 2011	Recall initiated by company
9 Jun 2017	Classified by FDA	+2341 days
21 Jun 2017	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Video Cytoscopes

Where it was distributed

US Nationwide and Internationally

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US Nationwide and Internationally

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 77310

Reported	Class	Recall	Company	Reason	Where
21 Jun 2017	CLASS II	Video Bronchoscope recalled by Pentax of America	Pentax of America	Other	Nationwide
21 Jun 2017	CLASS II	Video Naso pharyngo Laryngoscopes recalled by Pentax of America	Pentax of America	Other	Nationwide

More recalls from Pentax of America

All 33

Reported	Class	Recall	Company	Reason	Where
27 Aug 2025Device	CLASS II	Pentax Medical Video Processor recalled by Pentax of America	Pentax of America	Other	20 states
5 Mar 2025Device	CLASS II	Pentax Medical Video Colonoscope- Intended to provide recalled	Pentax of America	Other	Nationwide
5 Mar 2025Device	CLASS II	Pentax Medical Video Upper GI Scope-Intended to provide recalled	Pentax of America	Other	Nationwide
5 Mar 2025Device	CLASS II	Pentax Medical Video Processor- Intended to be used recalled	Pentax of America	Other	Nationwide
22 Sep 2021Device	CLASS II	Colonoscope Family # 1-Pentax Video Colonoscopes recalled	Pentax of America	Other	Nationwide

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