CLASS II ONGOING Device recall · Reported 5 Mar 2025 · FDA Enforcement Report

Pentax Medical Video Upper GI Scope-Intended to provide recalled

Pentax of America is recalling Pentax Medical Video Upper GI Scope-Intended to provide optical visualization of (via a, distributed nationwide in the US. The recall was initiated on 29 Jan 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 04961333252145 Serial Numbers: A0038A0431 A0038A0433 A0038A0435 A0038A0447 A0038A0451 A0038A0452 A0038A0454 A0038A0458 A0038A0460 A0038A0474 A0038A0475 A0038A0479 A0038A0486 A0038A0488 A0038A0489 A0038A0492 A0038A0494 A0038A0496 A0038A0497 A0038A0500 A0038A0502 A0038A0503 A0038A0507 A0038A0513 A0038A0514 A0038A0516 A0038A0527 A0038A0529 A0038A0536 A0038A0538 A0038A0539 A0038A0541 A0038A0557 A0038A0558 A0038A0560 A0038A0563 A0038A0566 A0038A0568 A0038A0570 A0038A0573 A0038A0574 A0038A0575 A0038A0577 A0038A0579 A0038A0583 A0038A0584 A0038A0585 A0038A0594 A0038A0595 A0038A0596 A0038A0597 A0038A0598 A0038A0599 A0038A0600 A0038A0601 A0038A0602 A0038A0605 A0038A0606 A0038A0607 A0038A0608 A0038A0609 A0038A0610 A0038A0613 A0038A0615 A0038A0616 A0038A0617 A0038A0618 A0038A0619 A0038A0621 A0038A0622 A0038A0623 A0038A0624 A0038A0625 A0038A0630 A0038A0636 A0038A0638 A0038A0639 A0038A0640 A0038A0644 A0038A0645 A0038A0646 A0038A0647 A0038A0648 A0038A0654 A0038A0762 A0038A0786 A0038A0794 A0038AA005 A0038AA010 A0038AA022 A0038AA030 A0038AA039 A0038AA057 A0038AA066 A0038AA067 A0038AA069 A0038AB005 A0038AB008 A0038AB012 A0038AB022 A0038AB023 A0038AB024 A0038AB049 A0038AB055 A0038AB056 A0038AB060 A0038AB063 A0038AB084 A0038AB088 A0038AB124 A0038AB125 A0038AB129 A0038AB130 A0038AB131 A0038AB144 A0038AB152 A0038AB162 A0038AB163 A0038AB164 A0038AB168 A0038AB169 A0038AB170 A0038AB171 A0038AB172 A0038AB180 A0038AB181 A0038AB183 A0038AB184 A0038AB186 A0038AB188 A0038AB189 A0038AB193 A0038AB194 A0038AB195 A0038AB197 A0038AB198 A0038AB200 A0038AB205

Quantity recalled138 units

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-1237-2025
FDA event ID: 96164
Recalling firm: Pentax of America, Montvale, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 29 Jan 2025
FDA classified: 26 Feb 2025
Reported: 5 Mar 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

29 Jan 2025	Recall initiated by company
26 Feb 2025	Classified by FDA	+28 days
5 Mar 2025	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

During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.

Product as listed by the FDA

PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI: 04961333252145 Serial Numbers: A0038A0431 A0038A0433 A0038A0435 A0038A0447 A0038A0451 A0038A0452 A0038A0454 A0038A0458 A0038A0460 A0038A0474 A0038A0475 A0038A0479 A0038A0486 A0038A0488 A0038A0489 A0038A0492 A0038A0494 A0038A0496 A0038A0497 A0038A0500 A0038A0502 A0038A0503 A0038A0507 A0038A0513 A0038A0514 A0038A0516 A0038A0527 A0038A0529 A0038A0536 A0038A0538 A0038A0539 A0038A0541 A0038A0557 A0038A0558 A0038A0560 A0038A0563 A0038A0566 A0038A0568 A0038A0570 A0038A0573 A0038A0574 A0038A0575 A0038A0577 A0038A0579 A0038A0583 A0038A0584 A0038A0585 A0038A0594 A0038A0595 A0038A0596 A0038A0597 A0038A0598 A0038A0599 A0038A0600 A0038A0601 A0038A0602 A0038A0605 A0038A0606 A0038A0607 A0038A0608 A0038A0609 A0038A0610 A0038A0613 A0038A0615 A0038A0616 A0038A0617 A0038A0618 A0038A0619 A0038A0621 A0038A0622 A0038A0623 A0038A0624 A0038A0625 A0038A0630 A0038A0636 A0038A0638 A0038A0639 A0038A0640 A0038A0644 A0038A0645 A0038A0646 A0038A0647 A0038A0648 A0038A0654 A0038A0762 A0038A0786 A0038A0794 A0038AA005 A0038AA010 A0038AA022 A0038AA030 A0038AA039 A0038AA057 A0038AA066 A0038AA067 A0038AA069 A0038AB005 A0038AB008 A0038AB012 A0038AB022 A0038AB023 A0038AB024 A0038AB049 A0038AB055 A0038AB056 A0038AB060 A0038AB063 A0038AB084 A0038AB088 A0038AB124 A0038AB125 A0038AB129 A0038AB130 A0038AB131 A0038AB144 A0038AB152 A0038AB162 A0038AB163 A0038AB164 A0038AB168 A0038AB169 A0038AB170 A0038AB171 A0038AB172 A0038AB180 A0038AB181 A0038AB183 A0038AB184 A0038AB186 A0038AB188 A0038AB189 A0038AB193 A0038AB194 A0038AB195 A0038AB197 A0038AB198 A0038AB200 A0038AB205

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

2 other products · FDA event 96164

This product is part of a recall event; the main page for the event is Pentax Medical Video Processor- Intended to be used recalled.

Reported	Class	Recall	Company	Reason	Where
5 Mar 2025	CLASS II	Pentax Medical Video Processor- Intended to be used recalled	Pentax of America	Other	Nationwide
5 Mar 2025	CLASS II	Pentax Medical Video Colonoscope- Intended to provide 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 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
22 Sep 2021Device	CLASS II	Gastroscope Family # 1-Gastroscopes without a Water Jet Channel recalled	Pentax of America	Other	Nationwide

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14 Oct 2026Device	CLASS III	Panorama and Telemetry Monitoring System recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide