Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
FDA Device Recall #Z-0970-2024 — Class II — December 18, 2023
Recall Summary
| Recall Number | Z-0970-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 18, 2023 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Vortex Surgical Inc. |
| Location | Saint Charles, MO |
| Product Type | Devices |
| Quantity | 800 devices |
Product Description
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Reason for Recall
Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea
Lot / Code Information
UDI/DI 00810123481132, Lot Numbers 2212002 and 2212020
Other Recalls from Vortex Surgical Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1244-2026 | Class II | Volk Single Use Vitrectomy Lenses 1. Flat Vi... | Dec 16, 2025 |
| Z-1251-2026 | Class II | Tecfen Retractable Membrane Polisher, QTPR1267-23 | Dec 16, 2025 |
| Z-1248-2026 | Class II | 25GA Subretinal Injection Cannula VS0220.25 | Dec 16, 2025 |
| Z-1247-2026 | Class II | Vortex Disposable Forceps and Cannula 1. 23G... | Dec 16, 2025 |
| Z-1250-2026 | Class II | Vortex Surgical 25GA I.D.D. Internal Delivery D... | Dec 16, 2025 |
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.