# Vortex Surgical, Inc. > Medical device manufacturer record on deviCERTS, compiled from public registries. 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. - Canonical page: - Also registered as: Vortex Surgical - Country: United States (from SRN) - EUDAMED actor status: active - Role: Manufacturer - Registrations: EUDAMED - EUDAMED SRN: US-MF-000022888 - DUNS: 080375891 ## Figures - Devices: 185 - FDA recalls (matched to the firm by name): 15, 14 ongoing ## Registry facts *Every device of the manufacturer. A device listed in two registries counts in both.* - Registries: FDA GUDID 152, EUDAMED 69 - Device classes: FDA Class I 91, EU Class IIa 64, FDA Class II 30 - EMDN [Q02 Ophthalmic devices](https://devicerts.com/categories/emdn/Q02): 64 devices - EMDN [A01 Needles](https://devicerts.com/categories/emdn/A01): 1 devices ## Sites and related companies - Authorised representative: [Emergo Europe B.V.](https://devicerts.com/representatives/emergo-europe-bv-nl-ar-000000116) (Netherlands) ## Devices The first 50 of 185, in the order of the canonical page, which lists them all. - [Tecfen Retractable Membrane Polisher 25G Box of 5](https://devicerts.com/devices/tecfen-retractable-membrane-polisher-25g-box-of-5-qtpr1267-25) · ref QTPR1267-25 · Class IIa · EUDAMED · status: Active - [23ga Embrace Elevator Box of 5](https://devicerts.com/devices/23ga-embrace-elevator-box-of-5-vs0370-23) · ref VS0370.23 · Class IIa · EUDAMED · status: Active - [Tecfen Retractable Membrane Polisher 23G Box of 5](https://devicerts.com/devices/tecfen-retractable-membrane-polisher-23g-box-of-5-qtpr1267-23) · ref QTPR1267-23 · Class IIa · EUDAMED · status: Active - [Tecfen Membrane Polisher 23G Box of 5](https://devicerts.com/devices/tecfen-membrane-polisher-23g-box-of-5-qtp1267-23) · ref QTP1267-23 · Class IIa · EUDAMED · status: Active - [27ga Intuitive Extendable MaxReach Laser Probe Box of 5](https://devicerts.com/devices/27ga-intuitive-extendable-maxreach-laser-probe-box-of-5-vs0142-27) · ref VS0142.27 · Class IIa · EUDAMED · status: Active - [23ga Intuitive Extendable MaxReach Laser Probe Box of 5](https://devicerts.com/devices/23ga-intuitive-extendable-maxreach-laser-probe-box-of-5-vs0142-23) · ref VS0142.23 · Class IIa · EUDAMED · status: Active - [Tecfen Membrane Polisher 25G Box of 5](https://devicerts.com/devices/tecfen-membrane-polisher-25g-box-of-5-qtp1267-25) · ref QTP1267-25 · Class IIa · EUDAMED · status: Active - [25ga Intuitive Extendable MaxReach Laser Probe Box of 5](https://devicerts.com/devices/25ga-intuitive-extendable-maxreach-laser-probe-box-of-5-vs0142-25) · ref VS0142.25 · Class IIa · EUDAMED · status: Active - [25ga Embrace Elevator Box of 5](https://devicerts.com/devices/25ga-embrace-elevator-box-of-5-vs0370-25) · ref VS0370.25 · Class IIa · EUDAMED · status: Active - [Versatile Soft Tip 23ga](https://devicerts.com/devices/versatile-soft-tip-vs0280-23) · Class I · GUDID · status: Listed - [Retractable ILM Elevator 23ga](https://devicerts.com/devices/retractable-ilm-elevator-vs0350-23) · Class I · GUDID · status: Listed - [I² Kit for intraocular injection VS0510](https://devicerts.com/devices/i2-kit-for-intraocular-injection-vs0510) · Class I · GUDID · status: Listed - [20ga Bending Laser Probe - Alcon Compatible VS0140.20A](https://devicerts.com/devices/20ga-bending-laser-probe-alcon-compatible-vs0140-20a) · Class II · GUDID · status: Active - [Vortex Surgical Inc VS0640.25-XEX](https://devicerts.com/devices/vortex-surgical-inc-vs0640-25-xex) · Class I · GUDID · status: Listed - [Vortex Surgical Inc VS0743.25](https://devicerts.com/devices/vortex-surgical-inc-vs0743-25) · Class I · GUDID · status: Listed - [Vortex Surgical Inc VS0742.23](https://devicerts.com/devices/vortex-surgical-inc-vs0742-23) · Class I · GUDID · status: Listed - [Vortex Surgical Inc VS0802](https://devicerts.com/devices/vortex-surgical-inc-vs0802) · Class I · GUDID · status: Listed - [Vortex Surgical Inc VS0225C](https://devicerts.com/devices/vortex-surgical-inc-vs0225c) · Class I · GUDID · status: Listed - [25ga Curved Laser Probe VS0120.25](https://devicerts.com/devices/25ga-curved-laser-probe-vs0120-25-adfaf8c9) · Class II · GUDID · status: Listed - [TID - Todorich Illuminated Depressor VS0800](https://devicerts.com/devices/tid-todorich-illuminated-depressor-vs0800) · Class I · GUDID · status: Listed - [Vortex Surgical Inc VS0644.25-FXX](https://devicerts.com/devices/vortex-surgical-inc-vs0644-25-fxx) · Class I · GUDID · status: Listed - [Vortex Surgical Inc. VS0803](https://devicerts.com/devices/vortex-surgical-inc-vs0803) · Class II · GUDID · status: Listed - [Vortex Surgical Inc VS0740.23](https://devicerts.com/devices/vortex-surgical-inc-vs0740-23) · Class I · GUDID · status: Listed - [Vortex Surgical Inc VS0202.27](https://devicerts.com/devices/vortex-surgical-inc-vs0202-27) · Class I · GUDID · status: Listed - [Vortex Surgical Inc VS0350.25](https://devicerts.com/devices/vortex-surgical-inc-vs0350-25) · Class I · EUDAMED, GUDID · status: Active - [Vortex Surgical Inc VS0640.25-FEX](https://devicerts.com/devices/vortex-surgical-inc-vs0640-25-fex) · Class I · GUDID · status: Listed - [Vortex Surgical Inc VS0201.27](https://devicerts.com/devices/vortex-surgical-inc-vs0201-27) · Class I · GUDID · status: Listed - [25ga Bending Laser Probe - Iridex Compatible VS0140.25I](https://devicerts.com/devices/25ga-bending-laser-probe-iridex-compatible-vs0140-25i) · Class II · GUDID · status: Active - [25ga Flexible Tapered Laser Probe - Alcon Compatible VS0130.25A](https://devicerts.com/devices/25ga-flexible-tapered-laser-probe-alcon-compatible-vs0130-25a) · Class II · GUDID · status: Active - [23ga Bending Laser Probe - Alcon Compatible VS0140.23A](https://devicerts.com/devices/23ga-bending-laser-probe-alcon-compatible-vs0140-23a) · Class II · GUDID · status: Active - [27ga Straight Laser Probe VS0110.27](https://devicerts.com/devices/27ga-straight-laser-probe-vs0110-27-a1b82ed5) · Class II · GUDID · status: Listed - [Vortex Surgical Inc VS0280.23](https://devicerts.com/devices/vortex-surgical-inc-vs0280-23) · Class I · GUDID · status: Listed - [Vortex Surgical Inc VS0205.25B](https://devicerts.com/devices/vortex-surgical-inc-vs0205-25b) · Class I · GUDID · status: Listed - [Vortex Surgical Inc VS0744.27-35](https://devicerts.com/devices/vortex-surgical-inc-vs0744-27-35) · Class I · GUDID · status: Listed - [Vortex Surgical Inc VS0743.25-35](https://devicerts.com/devices/vortex-surgical-inc-vs0743-25-35) · Class I · EUDAMED, GUDID · status: Active - [Vortex Surgical Inc VS0640.23-XEX](https://devicerts.com/devices/vortex-surgical-inc-vs0640-23-xex) · Class I · GUDID · status: Listed - [Vortex Surgical Inc VS0205.25](https://devicerts.com/devices/vortex-surgical-inc-vs0205-25) · Class I · GUDID · status: Listed - [27ga Soft Tip Cannula VS0200.27](https://devicerts.com/devices/27ga-soft-tip-cannula-vs0200-27) · Class I · GUDID · status: Listed - [27ga Curved Laser Probe VS0120.27](https://devicerts.com/devices/27ga-curved-laser-probe-vs0120-27-20acd5f8) · Class II · GUDID · status: Listed - [23ga Soft Tip Cannula VS0200.23](https://devicerts.com/devices/23ga-soft-tip-cannula-vs0200-23) · Class I · GUDID · status: Listed - [Vortex Surgical Inc. VS0753.27](https://devicerts.com/devices/vortex-surgical-inc-vs0753-27) · Class I · GUDID · status: Listed - [Vortex Surgical Inc VS0800](https://devicerts.com/devices/vortex-surgical-inc-vs0800) · Class I · GUDID · status: Listed - [Vortex Surgical Inc. VS0125.25](https://devicerts.com/devices/vortex-surgical-inc-vs0125-25) · Class II · GUDID · status: Listed - [Vortex Surgical Inc VS0520](https://devicerts.com/devices/vortex-surgical-inc-vs0520) · Class I · GUDID · status: Listed - [Vortex Surgical Inc VS0350.23](https://devicerts.com/devices/vortex-surgical-inc-vs0350-23) · Class I · EUDAMED, GUDID · status: Active - [25ga Flexible Tapered Laser Probe - Iridex Compatible VS0130.25I](https://devicerts.com/devices/25ga-flexible-tapered-laser-probe-iridex-compatible-vs0130-25i) · Class II · GUDID · status: Active - [Vortex Surgical Inc VS0280.25](https://devicerts.com/devices/vortex-surgical-inc-vs0280-25) · Class I · GUDID · status: Listed - [Vortex Surgical Inc VS0743.23](https://devicerts.com/devices/vortex-surgical-inc-vs0743-23) · Class I · GUDID · status: Listed - [Vortex Surgical Inc VS0640.23-XXS](https://devicerts.com/devices/vortex-surgical-inc-vs0640-23-xxs) · Class I · GUDID · status: Listed - [Vortex Surgical Inc VS0290](https://devicerts.com/devices/vortex-surgical-inc-vs0290) · Class I · GUDID · status: Listed ## FDA recalls (matched by name, newest first) - Z-1244-2026 · Class II · Ongoing · initiated 2025-12-16 · product code HJK: 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. - Z-1245-2026 · Class II · Ongoing · initiated 2025-12-16 · product code HQB: 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. - Z-1246-2026 · Class II · Ongoing · initiated 2025-12-16 · product code HQB: 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. - Z-1247-2026 · Class II · Ongoing · initiated 2025-12-16 · product code HNR: 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. - Z-1248-2026 · Class II · Ongoing · initiated 2025-12-16 · product code MXY: 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. - Z-1249-2026 · Class II · Ongoing · initiated 2025-12-16 · product code KDD: 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. - Z-1250-2026 · Class II · Ongoing · initiated 2025-12-16 · product code MXY: 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. - Z-1251-2026 · Class II · Ongoing · initiated 2025-12-16 · product code HNQ: 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. - Z-1252-2026 · Class II · Ongoing · initiated 2025-12-16 · product code KDD: 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. - Z-1253-2026 · Class II · Ongoing · initiated 2025-12-16 · product code HNQ: 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. - Z-1254-2026 · Class II · Ongoing · initiated 2025-12-16 · product code HJM: XXX - Z-1255-2026 · Class II · Ongoing · initiated 2025-12-16 · product code MXY: 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. - Z-1256-2026 · Class II · Ongoing · initiated 2025-12-16 · product code HMQ: 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. - Z-1004-2026 · Class II · Ongoing · initiated 2025-11-19 · product code HQB: Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly. - Z-0970-2024 · Class II · Terminated · initiated 2023-12-18 · product code HNR: 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. ## Source and citation - Cite as: Vortex Surgical, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/vortex-surgical-inc (data as of 2026-11-14). - Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/) - EUDAMED record synced: 2026-11-07 - FDA recall data as of: 2026-11-01 - Data as of: 2026-11-14 - JSON: - Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms. - Attribution: DevicErts, https://devicerts.com/manufacturers/vortex-surgical-inc - Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.