Vortex Surgical, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000022888
Vortex Surgical, Inc. is a medical device manufacturer based in the United States, with 185 devices listed in FDA GUDID and EUDAMED (FDA Class I and II; EU Class IIa) and 15 FDA recalls as of 14 Nov 2026.
- Devices
- 185
- Registrations
- EUDAMED
- FDA recalls
- 1514 ongoing
Registry facts
- Registries
- FDA GUDID 152
- EUDAMED 69
- Device classes
- FDA Class I 91
- EU Class IIa 64
- FDA Class II 30
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Emergo Europe B.V. authorised representative
- Identifiers
- EUDAMED SRN US-MF-000022888
- DUNS 080375891
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
- Authorised rep.
- Emergo Europe B.V.NL
What Vortex Surgical, Inc. makes
Vortex Surgical, Inc. manufactures single-use ophthalmic surgical instruments, including vitrectomy handpieces and cannulas for fluid and gas management, laser beam guides for ophthalmic procedures, and soft-tissue manipulation tools such as forceps and probes. Their portfolio also includes epiretinal/inner limiting membrane scrapers, fibreoptic light instruments, and laser-compatible probes designed for intraocular and retinal surgeries. Additional offerings encompass procedure kits for intraocular injections and illuminated depressors for surgical visualization.
The company’s devices are classified under FDA regulations as Class I, Class II, and Class IIa, with corresponding entries in the FDA’s Unique Device Identifier (UDI) database and the EU’s eudamed registry. These products are intended for use in the United States and European markets, adhering to applicable regulatory standards for surgical and diagnostic ophthalmic instruments.
Catalogue
Search and filter all 185 devicesShowing 1-50 of 185
Company details
- EUDAMED SRN
- US-MF-000022888
- DUNS number
- 080375891
- EUDAMED status
- Active
- EUDAMED registered name
- Vortex Surgical Inc
- Registered address
- 4, Research Park Dr, 63304, Saint Charles, United States
- Phone
- 6367784350
- PRRC contact
- Andrew Ritts
FDA recalls
FDA recall records list 15 recalls initiated by Vortex Surgical, Inc., the earliest on 2023-12-18 and the most recent on 2025-12-16. By recorded status: 14 ongoing and 1 terminated. The reasons filed fall into these groups: sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 1
- 2024 0
- 2025 14
- 2026 0
2025
- 16 Dec 2025 Z-1244-2026 Class II Ongoing 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.
Full distribution text
- 16 Dec 2025 Z-1245-2026 Class II Ongoing 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.
Full distribution text
- 16 Dec 2025 Z-1246-2026 Class II Ongoing 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.
Full distribution text
- 16 Dec 2025 Z-1247-2026 Class II Ongoing 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.
Full distribution text
- 16 Dec 2025 Z-1248-2026 Class II Ongoing 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.
Full distribution text
- 16 Dec 2025 Z-1249-2026 Class II Ongoing 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.
Full distribution text
- 16 Dec 2025 Z-1250-2026 Class II Ongoing 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.
Full distribution text
- 16 Dec 2025 Z-1251-2026 Class II Ongoing 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.
Full distribution text
- 16 Dec 2025 Z-1252-2026 Class II Ongoing 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.
Full distribution text
- 16 Dec 2025 Z-1253-2026 Class II Ongoing 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.
Full distribution text
- 16 Dec 2025 Z-1244-2026 Class II Ongoing 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.
Show all 15 recalls
2025
- 16 Dec 2025 Z-1254-2026 Class II Ongoing XXX
Full distribution text
- 16 Dec 2025 Z-1255-2026 Class II Ongoing 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.
Full distribution text
- 16 Dec 2025 Z-1256-2026 Class II Ongoing 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.
Full distribution text
- 19 Nov 2025 Z-1004-2026 Class II Ongoing Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
- 16 Dec 2025 Z-1254-2026 Class II Ongoing XXX
2023
- 18 Dec 2023 Z-0970-2024 Class II Terminated 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.
Frequently asked questions
How many devices does Vortex Surgical, Inc. have in the registry?
The registry currently lists 185 devices for Vortex Surgical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vortex Surgical, Inc.'s devices?
Among its 50 most recently registered devices, Vortex Surgical, Inc. has devices listed in EUDAMED (12 devices) and FDA GUDID (41 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Vortex Surgical, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Vortex Surgical, Inc.'s devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Vortex Surgical, Inc.?
FDA recall records list 15 recalls initiated by Vortex Surgical, Inc., the most recent initiated on 16 Dec 2025. 14 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Vortex Surgical, Inc. in the registry?
The most recently registered devices listed for Vortex Surgical, Inc. include Tecfen Retractable Membrane Polisher 25G Box of 5, 23ga Embrace Elevator Box of 5, Tecfen Retractable Membrane Polisher 23G Box of 5 and Tecfen Membrane Polisher 23G Box of 5.