Vortex Surgical Inc.
Medical device manufacturer in Saint Charles, MO.
2510(k) clearances
0PMA approvals
15recalls
Device types
510(k) clearances
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1256-2026 Class II | Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral MarkerThere may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1255-2026 Class II | Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1254-2026 Class II | Vortex Surgical TID Pharos Illuminated Depressor, VS0801BXXX | 12/16/2025Open, Classified |
| Z-1253-2026 Class II | Rumex Disposable Diamond Dusted ILM Elevator, 12-7523There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1252-2026 Class II | Vortex Surgical I2 Injection Kit, VS0500There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1251-2026 Class II | Tecfen Retractable Membrane Polisher, QTPR1267-23There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1250-2026 Class II | Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1249-2026 Class II | Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit -…There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1248-2026 Class II | 25GA Subretinal Injection Cannula VS0220.25There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1247-2026 Class II | Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA…There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1246-2026 Class II | Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated…There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1245-2026 Class II | Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved…There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1244-2026 Class II | Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk…There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1004-2026 Class II | Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly. | 11/19/2025Open, Classified |
| Z-0970-2024 Class II | Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea.… | 12/18/2023Terminated |