Vortex Surgical Inc.
14 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Vortex Surgical Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-02-11FDA-DeviceClass IIVortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2026-02-11FDA-DeviceClass IIVortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2026-02-11FDA-DeviceClass IIVortex Surgical TID Pharos Illuminated Depressor, VS0801B
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- 2026-02-11FDA-DeviceClass IIRumex Disposable Diamond Dusted ILM Elevator, 12-7523
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2026-02-11FDA-DeviceClass IIVortex Surgical I2 Injection Kit, VS0500
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2026-02-11FDA-DeviceClass IITecfen Retractable Membrane Polisher, QTPR1267-23
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2026-02-11FDA-DeviceClass IIVortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2026-02-11FDA-DeviceClass IIConvenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2026-02-11FDA-DeviceClass II25GA Subretinal Injection Cannula VS0220.25
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2026-02-11FDA-DeviceClass IIVortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2026-02-11FDA-DeviceClass IIOertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2026-02-11FDA-DeviceClass IIVortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25 6. 25GA Laser Probe Straight Cat No. VS0110.25
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2026-02-11FDA-DeviceClass IIVolk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2026-01-07FDA-DeviceClass IIVortex 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.
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