Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in en...
FDA Device Recall #Z-1009-2019 — Class II — December 17, 2018
Recall Summary
| Recall Number | Z-1009-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 17, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Olympus Corporation of the Americas |
| Location | Center Valley, PA |
| Product Type | Devices |
| Quantity | 2 |
Product Description
Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Reason for Recall
The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
Distribution Pattern
US Nationwide distribution in the states of CT, IL, MN, MO, and NC.
Lot / Code Information
Serial Number 2501374 and 2704914
Other Recalls from Olympus Corporation of the Americas
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1909-2026 | Class II | OER-ELITE Endoscope Reprocessor Connecting Tube... | Mar 25, 2026 |
| Z-1904-2026 | Class II | OER-ELITE Endoscope Reprocessor Connecting Tube... | Mar 25, 2026 |
| Z-1899-2026 | Class II | OER-ELITE Endoscope Reprocessor Connecting Tube... | Mar 25, 2026 |
| Z-1898-2026 | Class II | OER-ELITE Endoscope Reprocessor Connecting Tube... | Mar 25, 2026 |
| Z-1905-2026 | Class II | OER-ELITE Endoscope Reprocessor Connecting Tube... | Mar 25, 2026 |
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.