Vortex Surgical Inc.

FDA Regulatory Profile

Summary

Total Recalls
15
510(k) Clearances
2
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1253-2026Class IIRumex Disposable Diamond Dusted ILM Elevator, 12-7523December 16, 2025
Z-1249-2026Class IIConvenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VDecember 16, 2025
Z-1251-2026Class IITecfen Retractable Membrane Polisher, QTPR1267-23December 16, 2025
Z-1254-2026Class IIVortex Surgical TID Pharos Illuminated Depressor, VS0801BDecember 16, 2025
Z-1255-2026Class IIVortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27December 16, 2025
Z-1250-2026Class IIVortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25December 16, 2025
Z-1256-2026Class IIVortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral MarkerDecember 16, 2025
Z-1244-2026Class IIVolk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, December 16, 2025
Z-1245-2026Class IIVortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat December 16, 2025
Z-1248-2026Class II25GA Subretinal Injection Cannula VS0220.25December 16, 2025
Z-1252-2026Class IIVortex Surgical I2 Injection Kit, VS0500December 16, 2025
Z-1247-2026Class IIVortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 December 16, 2025
Z-1246-2026Class IIOertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VKDecember 16, 2025
Z-1004-2026Class IIVortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;November 19, 2025
Z-0970-2024Class IIVortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25December 18, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K220263Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical EndoilluminaNovember 3, 2022
K191846MAXReach Laser ProbeDecember 23, 2019