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PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video moni...

FDA Device Recall #Z-1236-2025 — Class II — January 29, 2025

Recall Summary

Recall Number Z-1236-2025
Classification Class II — Moderate risk
Date Initiated January 29, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Pentax of America Inc
Location Montvale, NJ
Product Type Devices
Quantity 152 units

Product Description

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

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.

Distribution Pattern

Nationwide

Lot / Code Information

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

Other Recalls from Pentax of America Inc

Recall # Classification Product Date
Z-2329-2025 Class II Pentax Medical Video Processor; Model Number: ... Jul 16, 2025
Z-1238-2025 Class II Pentax Medical Video Processor- Intended to be ... Jan 29, 2025
Z-1237-2025 Class II PENTAX Medical Video Upper GI Scope-Intended to... Jan 29, 2025
Z-2448-2021 Class II Colonoscope Family # 1-Pentax Video Colonoscope... Jul 14, 2021
Z-2449-2021 Class II Gastroscope Family # 1-Gastroscopes without a W... Jul 14, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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