Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-24...
FDA Device Recall #Z-2449-2021 — Class II — July 14, 2021
Recall Summary
| Recall Number | Z-2449-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 14, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Pentax of America Inc |
| Location | Montvale, NJ |
| Product Type | Devices |
| Quantity | 28849 units Total |
Product Description
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK
Reason for Recall
Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
Distribution Pattern
Nationwide
Lot / Code Information
All devices distributed by Pentax in the US between April 2014 and May 2021
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-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 |
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.