Chrysalis Intelligence · Sponsors · Vortex Surgical, Inc.

Vortex Surgical, Inc.

Chesterfield, MO, US · 1 510(k) clearances · 16 recalls

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Total clearances
1
2022-11-03 → 2022-11-03
Last 12 months
0
Product codes
1
Most recent
2022-11-03
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HQB Photocoagulator And Accessories Class II Ophthalmic 1 2022-11-03
Safety

Recalls (16)

Class I (serious)
0
Risk of injury / death
Total recalls
16
Currently ongoing
15
Most recent
2025-12-16
DateSeverityStatusRecall # ProductCodeReason
2025-12-16 Class II Ongoing Z-1256-2026 Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker — 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 biob…
2025-12-16 Class II Ongoing Z-1255-2026 Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27 — 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 biob…
2025-12-16 Class II Ongoing Z-1254-2026 Vortex Surgical TID Pharos Illuminated Depressor, VS0801B — XXX
2025-12-16 Class II Ongoing Z-1253-2026 Rumex Disposable Diamond Dusted ILM Elevator, 12-7523 — 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 biob…
2025-12-16 Class II Ongoing Z-1252-2026 Vortex Surgical I2 Injection Kit, VS0500 — 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 biob…
2025-12-16 Class II Ongoing Z-1251-2026 Tecfen Retractable Membrane Polisher, QTPR1267-23 — 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 biob…
2025-12-16 Class II Ongoing Z-1250-2026 Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25 — 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 biob…
2025-12-16 Class II Ongoing Z-1249-2026 Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25… — 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 biob…
2025-12-16 Class II Ongoing Z-1249-2026 Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25… — 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 biob…
2025-12-16 Class II Ongoing Z-1248-2026 25GA Subretinal Injection Cannula VS0220.25 — 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 biob…
2025-12-16 Class II Ongoing Z-1247-2026 Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS… — 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 biob…
2025-12-16 Class II Ongoing Z-1246-2026 Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Las… — 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 biob…
2025-12-16 Class II Ongoing Z-1245-2026 Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. … — 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 biob…
2025-12-16 Class II Ongoing Z-1244-2026 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 biob…
2025-11-19 Class II Ongoing Z-1004-2026 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.
2023-12-18 Class II Terminated Z-0970-2024 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…
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2022-11-03 K220263 Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers HQB Class II Ophthalmic
Data source: openFDA · Generated 2026-09-07 09:19 · Last ingest 2026-09-07T13:19:27.426703 · Pipeline: Chrysalis Intelligence