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Vortex Surgical Inc. FDA Recalls

15 recalls on file across devices, 0 of them Class I and 14 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral MarkerClass IIDec 16, 2025There may be voids located in the seal of Tyvek pouches asso
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25Class IIDec 16, 2025There may be voids located in the seal of Tyvek pouches asso
Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G LasClass IIDec 16, 2025There may be voids located in the seal of Tyvek pouches asso
Tecfen Retractable Membrane Polisher, QTPR1267-23Class IIDec 16, 2025There may be voids located in the seal of Tyvek pouches asso
25GA Subretinal Injection Cannula VS0220.25Class IIDec 16, 2025There may be voids located in the seal of Tyvek pouches asso
Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VSClass IIDec 16, 2025There may be voids located in the seal of Tyvek pouches asso
Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. Class IIDec 16, 2025There may be voids located in the seal of Tyvek pouches asso
Rumex Disposable Diamond Dusted ILM Elevator, 12-7523Class IIDec 16, 2025There may be voids located in the seal of Tyvek pouches asso
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25Class IIDec 16, 2025There may be voids located in the seal of Tyvek pouches asso
Vortex Surgical TID Pharos Illuminated Depressor, VS0801BClass IIDec 16, 2025XXX
Vortex Surgical I2 Injection Kit, VS0500Class IIDec 16, 2025There may be voids located in the seal of Tyvek pouches asso
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27Class IIDec 16, 2025There may be voids located in the seal of Tyvek pouches asso
Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMDClass IIDec 16, 2025There may be voids located in the seal of Tyvek pouches asso
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;Class IINov 19, 2025Reason for the voluntary recall is some products in this lot
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25Class IIDec 18, 2023Reason for the voluntary recall is residue was identified on

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