Data / Medical devices / United States / Vortex Surgical, Inc.

Vortex Surgical, Inc.: FDA-registered device maker in Saint Charles, MO, United States, 4 510(k) clearances

Name: Vortex Surgical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Vortex Surgical, Inc. is registered with the FDA (registration 3013002167) in Saint Charles, MO, United States. It lists 13 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 3, 2022. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013002167
Address: 4 Research Park Dr Suite 124, Saint Charles, MO, United States, 63304
Owner or operator: Vortex Surgical, Inc. (10052162)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: November 28, 2016
Registered through: 2026
Brand names listed: ACTU8 Forceps, Beacon Illuminated Depressor, Injection Kits, JOD 27GA CANN W/ SILICONE TUBING TIP, MAXReach Laser Probe, Soft Tip Cannula, TID Pharos Illuminated Depressor, Todorich Illuminated Depressor (TID)

Devices it lists

Device	Product code	Class	Role	Source
Cannula, Ophthalmic	HMX	1	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	MXY	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Depressor, Orbital	HNX	1	Manufacturer	accessdata.fda.gov
Endoilluminator	MPA	2	Manufacturer	accessdata.fda.gov
Forceps, Ophthalmic	HNR	1	Manufacturer	accessdata.fda.gov
Hook, Ophthalmic	HNQ	1	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Manufacturer, Specification developer	accessdata.fda.gov
Led Light Source	NTN	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Lens, Contact, Polymethylmethacrylate, Diagnostic	HJK	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Light Source, Fiberoptic, Routine	FCW	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Marker, Sclera	HMQ	1	Manufacturer	accessdata.fda.gov
Photocoagulator And Accessories	HQB	2	Manufacturer	accessdata.fda.gov
Transilluminator, Ac-Powered	HJM	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 3, 2022	K220263	Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers	HQB	Substantially Equivalent	Vortex Surgical, Inc.	accessdata.fda.gov
December 23, 2019	K191846	MAXReach Laser Probe	HQB	Substantially Equivalent	Vortex Surgical, Inc.	accessdata.fda.gov
August 17, 2010	K102167	LO-50 LED LIGHT SOURCE	NTN	Substantially Equivalent	Fiberoptics Technology, Inc.	accessdata.fda.gov
March 28, 2005	K050623	VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D	HJK	Substantially Equivalent	Volk Optical, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 16, 2025	98255	Class II	Ongoing	Volk 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.	accessdata.fda.gov
November 19, 2025	98032	Class II	Ongoing	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.	accessdata.fda.gov
December 18, 2023	93725	Class II	Terminated	Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25	Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.	accessdata.fda.gov

Compare with other makers

Updated February 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.