CLASS II ONGOING Device recall · Reported 22 Sep 2021 · FDA Enforcement Report

Colonoscope Family # 1-Pentax Video Colonoscopes recalled

Pentax of America is recalling Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel, distributed nationwide in the US. The recall was initiated on 14 Jul 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll devices distributed by Pentax in the US between April 2014 and May 2021

Quantity recalled28849 units Total

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-2448-2021
FDA event ID: 88440
Recalling firm: Pentax of America, Montvale, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 14 Jul 2021
FDA classified: 10 Sep 2021
Reported: 22 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Jul 2021	Recall initiated by company
10 Sep 2021	Classified by FDA	+58 days
22 Sep 2021	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

Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families

Product as listed by the FDA

Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families

Which lots are affected?

All devices distributed by Pentax in the US between April 2014 and May 2021

Where was it sold?

Nationwide

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 88440

This product is part of a recall event; the main page for the event is Gastroscope Family # 1-Gastroscopes without a Water Jet Channel recalled.

Reported	Class	Recall	Company	Reason	Where
22 Sep 2021	CLASS II	Gastroscope Family # 1-Gastroscopes without a Water Jet Channel recalled	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	Gastroscope Family # 1-Gastroscopes without a Water Jet Channel recalled	Pentax of America	Other	Nationwide

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