CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report

Video Cystoscope recalled by Pentax of America

Pentax of America is recalling Video Cystoscope, distributed in 8 states. The recall was initiated on 13 Jul 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial number: J110097 J110101 G110053 G110051 G110052 G110054 G110015 G110084 H110086 H110088 J110062 G110016 G110039 G110048 G110049 G110038 J110061 G110021 J110078 G110056 G110057 G110073 G110037 G110058

Quantity recalled24

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-0615-2018
FDA event ID: 79131
Recalling firm: Pentax of America, Montvale, NJ
Classification: Class II
Status: Terminated
Recall initiated: 13 Jul 2017
FDA classified: 14 Feb 2018
Reported: 21 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

13 Jul 2017	Recall initiated by company
14 Feb 2018	Classified by FDA	+216 days
21 Feb 2018	Published in enforcement report	+7 days

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

Reason for recall

The video cytoscopes lack 510(k) premarket notification clearance.

Product as listed by the FDA

Video Cystoscope models ECY-1570 and ECY-1570K

Where it was distributed

Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.

California Illinois Maryland Michigan North Dakota New Hampshire New York South Dakota

Questions about this recall

Why was it recalled?

The video cytoscopes lack 510(k) premarket notification clearance.

Which lots are affected?

Serial number: J110097 J110101 G110053 G110051 G110052 G110054 G110015 G110084 H110086 H110088 J110062 G110016 G110039 G110048 G110049 G110038 J110061 G110021 J110078 G110056 G110057 G110073 G110037 G110058

Where was it sold?

Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.

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.

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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