Drug & Device Safety Atlas

FDA recall record · openFDA

Vortex Surgical Inc.

15 FDA recalls on record (2023–2025) — 15 device. 14 still ongoing.

0
Class I (most serious)
15
Class II
0
Class III
14
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromis 12
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly. 1
Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is 1
XXX 1

Recalls

Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25 Class II 2025-12-16 Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25; Class II 2025-11-19 Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. Class II 2025-12-16 Vortex Surgical TID Pharos Illuminated Depressor, VS0801B Class II 2025-12-16 Vortex Surgical I2 Injection Kit, VS0500 Class II 2025-12-16 Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27 Class II 2025-12-16 Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Las Class II 2025-12-16 Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25 Class II 2025-12-16 Tecfen Retractable Membrane Polisher, QTPR1267-23 Class II 2025-12-16 25GA Subretinal Injection Cannula VS0220.25 Class II 2025-12-16 Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS Class II 2025-12-16 Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD Class II 2025-12-16 Rumex Disposable Diamond Dusted ILM Elevator, 12-7523 Class II 2025-12-16 Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker Class II 2025-12-16 Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25 Class II 2023-12-18

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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