Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ul...
FDA Device Recall #Z-0506-2021 — Class II — October 16, 2020
Recall Summary
| Recall Number | Z-0506-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 16, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Olympus Corporation of the Americas |
| Location | Center Valley, PA |
| Product Type | Devices |
| Quantity | 49 |
Product Description
Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
Reason for Recall
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Distribution Pattern
Worldwide distribution - US Nationwide distribution. Model Name ------------ Quantity distributed in U.S. GF-UC140P-AL5 ------------- 1,297 devices GF-UCT150-AL5 ------------- 564 devices GF-UCT180 -------------------- 3,145 devices GF-UM20 ----------------------- 31 devices GF-UM130 --------------------- 27 devices GF-UMQ130 ------------------- 373 devices GF-UM160 --------------------- 299 devices GF-UC160P-OL5 ------------- 46 devices GF-UCT160-OL5 ------------- 49 devices GF-UE160-AL5 -------------- 2,691 devices
Lot / Code Information
All Serial/Lot Numbers
Other Recalls from Olympus Corporation of the Americas
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1641-2026 | Class II | Brand Name: Olympus HALO PKS Cutting Forceps, 5... | Feb 25, 2026 |
| Z-1640-2026 | Class II | Brand Name: Olympus PK Cutting Forceps, 5mm 33c... | Feb 25, 2026 |
| Z-1642-2026 | Class II | Brand Name: Olympus PKS Cutting Forceps, 5mm 33... | Feb 25, 2026 |
| Z-1639-2026 | Class II | Brand Name: Olympus Everest Bipolar Cutting For... | Feb 25, 2026 |
| Z-1643-2026 | Class II | Brand Name: Olympus PKS Cutting Forceps w/Cord,... | Feb 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.