CLASS II Device recall · Reported 26 Feb 2020 · FDA Enforcement Report

Pentax Video Colonoscope recalled by Pentax of America

Pentax of America is recalling Pentax Video Colonoscope, distributed in Massachusetts, North Carolina. The recall was initiated on 3 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: L110300, L110301, L110303, L110306

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-1267-2020
FDA event ID: 84735
Recalling firm: Pentax of America, Montvale, NJ
Classification: Class II
Status: Terminated
Recall initiated: 3 Jan 2020
FDA classified: 19 Feb 2020
Reported: 26 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Jan 2020	Recall initiated by company
19 Feb 2020	Classified by FDA	+47 days
26 Feb 2020	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

Distributed in the USA without an approved 510K

Product as listed by the FDA

Pentax Video Colonoscope Model: EC34-i10L

Where it was distributed

NC, MA

Massachusetts North Carolina

Questions about this recall

Why was it recalled?

Distributed in the USA without an approved 510K

Which lots are affected?

Serial Numbers: L110300, L110301, L110303, L110306

Where was it sold?

NC, MA

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

1 other product · FDA event 84735

This product is part of a recall event; the main page for the event is Pentax Video Colonoscope recalled by Pentax of America.

Reported	Class	Recall	Company	Reason	Where
26 Feb 2020	CLASS II	Pentax Video Colonoscope recalled by Pentax of America	Pentax of America	Other	MA, NC

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

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide