Vortex Surgical Inc.
Vortex Surgical Inc. appears in FDA public data with 15 recalls, 2 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1246-2026, Class II) was initiated on December 16, 2025. Its most recent 510(k) clearance was granted on November 3, 2022.
Summary
- Total Recalls
- 15
- 510(k) Clearances
- 2
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1246-2026 | Class II | Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK | December 16, 2025 |
| Z-1244-2026 | Class II | Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, | December 16, 2025 |
| Z-1253-2026 | Class II | Rumex Disposable Diamond Dusted ILM Elevator, 12-7523 | December 16, 2025 |
| Z-1251-2026 | Class II | Tecfen Retractable Membrane Polisher, QTPR1267-23 | December 16, 2025 |
| Z-1256-2026 | Class II | Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker | December 16, 2025 |
| Z-1252-2026 | Class II | Vortex Surgical I2 Injection Kit, VS0500 | December 16, 2025 |
| Z-1254-2026 | Class II | Vortex Surgical TID Pharos Illuminated Depressor, VS0801B | December 16, 2025 |
| Z-1255-2026 | Class II | Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27 | December 16, 2025 |
| Z-1250-2026 | Class II | Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25 | December 16, 2025 |
| Z-1248-2026 | Class II | 25GA Subretinal Injection Cannula VS0220.25 | December 16, 2025 |
| Z-1245-2026 | Class II | Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat | December 16, 2025 |
| Z-1249-2026 | Class II | Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX V | December 16, 2025 |
| Z-1247-2026 | Class II | Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 | December 16, 2025 |
| Z-1004-2026 | Class II | Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25; | November 19, 2025 |
| Z-0970-2024 | Class II | Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25 | December 18, 2023 |