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PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video mon...

FDA Device Recall #Z-1237-2025 — Class II — January 29, 2025

Recall Summary

Recall Number Z-1237-2025
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 138 units

Product Description

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

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: 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

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-1236-2025 Class II PENTAX Medical Video Colonoscope- Intended to ... Jan 29, 2025
Z-1238-2025 Class II Pentax Medical Video Processor- Intended to be ... 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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