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

Pentax Medical Video Colonoscope- Intended to provide recalled

Pentax of America is recalling Pentax Medical Video Colonoscope- 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: 04961333252169 Serial Numbers: A002FA0230 A002FA0244 A002FA0246 A002FA0247 A002FA0248 A002FA0259 A002FA0269 A002FA0271 A002FA0272 A002FA0274 A002FA0275 A002FA0278 A002FA0281 A002FA0282 A002FA0283 A002FA0293 A002FA0294 A002FA0299 A002FA0300 A002FA0301 A002FA0303 A002FA0304 A002FA0306 A002FA0307 A002FA0311 A002FA0314 A002FA0315 A002FA0316 A002FA0321 A002FA0324 A002FA0364 A002FA0371 A002FA0372 A002FA0376 A002FA0378 A002FA0381 A002FA0383 A002FA0384 A002FA0388 A002FA0390 A002FA0399 A002FA0408 A002FA0415 A002FA0418 A002FA0419 A002FA0420 A002FA0422 A002FA0423 A002FA0424 A002FA0428 A002FA0432 A002FA0433 A002FA0435 A002FA0436 A002FA0437 A002FA0438 A002FA0439 A002FA0440 A002FA0443 A002FA0445 A002FA0446 A002FA0460 A002FA0462 A002FA0466 A002FA0474 A002FA0476 A002FA0477 A002FA0479 A002FA0485 A002FA0486 A002FA0487 A002FA0491 A002FA0492 A002FA0493 A002FA0496 A002FA0497 A002FA0505 A002FA0506 A002FA0514 A002FA0523 A002FA0539 A002FA0570 A002FA0578 A002FA0579 A002FA0580 A002FA0581 A002FA0592 A002FA0593 A002FA0594 A002FA0595 A002FA0596 A002FA0597 A002FA0604 A002FA0610 A002FA0611 A002FA0612 A002FA0613 A002FA0617 A002FA0619 A002FA0622 A002FA0633 A002FAA002 A002FAA005 A002FAA009 A002FAA010 A002FAA012 A002FAA017 A002FAA018 A002FAA021 A002FAA023 A002FAA024 A002FAA025 A002FAA026 A002FAA029 A002FAA030 A002FAA033 A002FAA034 A002FAA035 A002FAA036 A002FAA038 A002FAA051 A002FAA053 A002FAA056 A002FAA058 A002FAA065 A002FAA067 A002FAB002 A002FAB006 A002FAB018 A002FAB020 A002FAB024 A002FAB025 A002FAB026 A002FAB027 A002FAB029 A002FAB032 A002FAB048 A002FAB049 A002FAB050 A002FAB052 A002FAB053 A002FAB055 A002FAB057 A002FAB074 A002FAB076 A002FAB082 A002FAB084 A002FAB086 A002FAB097 A002FAB130 A002FAB132 A002FAB146

Quantity recalled152 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-1236-2025
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 Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI: 04961333252169 Serial Numbers: A002FA0230 A002FA0244 A002FA0246 A002FA0247 A002FA0248 A002FA0259 A002FA0269 A002FA0271 A002FA0272 A002FA0274 A002FA0275 A002FA0278 A002FA0281 A002FA0282 A002FA0283 A002FA0293 A002FA0294 A002FA0299 A002FA0300 A002FA0301 A002FA0303 A002FA0304 A002FA0306 A002FA0307 A002FA0311 A002FA0314 A002FA0315 A002FA0316 A002FA0321 A002FA0324 A002FA0364 A002FA0371 A002FA0372 A002FA0376 A002FA0378 A002FA0381 A002FA0383 A002FA0384 A002FA0388 A002FA0390 A002FA0399 A002FA0408 A002FA0415 A002FA0418 A002FA0419 A002FA0420 A002FA0422 A002FA0423 A002FA0424 A002FA0428 A002FA0432 A002FA0433 A002FA0435 A002FA0436 A002FA0437 A002FA0438 A002FA0439 A002FA0440 A002FA0443 A002FA0445 A002FA0446 A002FA0460 A002FA0462 A002FA0466 A002FA0474 A002FA0476 A002FA0477 A002FA0479 A002FA0485 A002FA0486 A002FA0487 A002FA0491 A002FA0492 A002FA0493 A002FA0496 A002FA0497 A002FA0505 A002FA0506 A002FA0514 A002FA0523 A002FA0539 A002FA0570 A002FA0578 A002FA0579 A002FA0580 A002FA0581 A002FA0592 A002FA0593 A002FA0594 A002FA0595 A002FA0596 A002FA0597 A002FA0604 A002FA0610 A002FA0611 A002FA0612 A002FA0613 A002FA0617 A002FA0619 A002FA0622 A002FA0633 A002FAA002 A002FAA005 A002FAA009 A002FAA010 A002FAA012 A002FAA017 A002FAA018 A002FAA021 A002FAA023 A002FAA024 A002FAA025 A002FAA026 A002FAA029 A002FAA030 A002FAA033 A002FAA034 A002FAA035 A002FAA036 A002FAA038 A002FAA051 A002FAA053 A002FAA056 A002FAA058 A002FAA065 A002FAA067 A002FAB002 A002FAB006 A002FAB018 A002FAB020 A002FAB024 A002FAB025 A002FAB026 A002FAB027 A002FAB029 A002FAB032 A002FAB048 A002FAB049 A002FAB050 A002FAB052 A002FAB053 A002FAB055 A002FAB057 A002FAB074 A002FAB076 A002FAB082 A002FAB084 A002FAB086 A002FAB097 A002FAB130 A002FAB132 A002FAB146

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 Upper GI Scope-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 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
22 Sep 2021Device	CLASS II	Gastroscope Family # 1-Gastroscopes without a Water Jet Channel recalled	Pentax of America	Other	Nationwide

Other Patient Monitors recalls

All 1,022

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS III	Passport Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	T1 Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	cPM Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	BeneVision Series Telemetry Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	Panorama and Telemetry Monitoring System recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide