Vortex Surgical Inc.
Vortex Surgical Inc. has 3 FDA enforcement events on this register (15 product records) between 2023 and 2025: 3 device; the busiest year was 2025 with 2.
0% of its events are Class I; the most common class is Class II (3). 2 events are listed as ongoing; the recalling firm's address is in MO.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 16 Dec 2025 | Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD | Device | Class II | 13 | Ongoing |
| 19 Nov 2025 | Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25; | Device | Class II | 1 | Ongoing |
| 18 Dec 2023 | Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25 | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Vortex Surgical Inc. had?
3 enforcement events (15 product records) on this register, 2023–2025: 3 device.
Are any Vortex Surgical Inc. recalls ongoing?
2 events are listed as ongoing in the current openFDA export.
What class are Vortex Surgical Inc. recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.