ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasoun...
FDA Device Recall #Z-1615-2023 — Class III — March 31, 2023
Recall Summary
| Recall Number | Z-1615-2023 |
| Classification | Class III — Low risk |
| Date Initiated | March 31, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Olympus Corporation of the Americas |
| Location | Center Valley, PA |
| Product Type | Devices |
| Quantity | 2058 (Boxes; 5 per Box) |
Product Description
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
Reason for Recall
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Distribution Pattern
Natiowide Foreign: Canada, Germany
Lot / Code Information
UDI: 04953170388248 Lot numbers: KR243729 KR248648 KR248652 KR248673 KR248784 KR248785 KR248808 KR249160 KR251593 KR257313 KR257314 KR264662 KR264697 KR264708 KR264711 KR264726 KR264732 KR264746 KR264751 KR264778 KR264806 KR276770
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.