Food, drugs, devices › Vortex Surgical Inc.
Device recall: Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
Vortex Surgical Inc. (Saint Charles, MO) initiated this device recall on 16 Dec 2025; FDA lists 13 product records under event 98255, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Vortex Surgical Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Vortex Surgical Inc., Saint Charles, MO.
Reason for recall
"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."
Distribution
"Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1244-2026 | Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD | 14,789 (8651 US; 6138 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1245-2026 | Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25 6. 25GA Laser Probe Straight Cat No. VS0110.25 | 14,789 (8651 US; 6138 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1246-2026 | Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe… | 14,789 (8651 US; 6138 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1247-2026 | Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps… | 14,789 (8651 US; 6138 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1248-2026 | 25GA Subretinal Injection Cannula VS0220.25 | 14,789 (8651 US; 6138 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1249-2026 | Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES | 14,789 (8651 US; 6138 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1250-2026 | Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25 | 14,789 (8651 US; 6138 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1251-2026 | Tecfen Retractable Membrane Polisher, QTPR1267-23 | 14,789 (8651 US; 6138 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1252-2026 | Vortex Surgical I2 Injection Kit, VS0500 | 14,789 (8651 US; 6138 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1253-2026 | Rumex Disposable Diamond Dusted ILM Elevator, 12-7523 | 14,789 (8651 US; 6138 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1254-2026 | Vortex Surgical TID Pharos Illuminated Depressor, VS0801B | 14,789 (8651 US; 6138 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1255-2026 | Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27 | 14,789 (8651 US; 6138 OUS) | Class II | Ongoing | 11 Feb 2026 |
| Z-1256-2026 | Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker | 14,789 (8651 US; 6138 OUS) | Class II | Ongoing | 11 Feb 2026 |
Context
Other enforcement events for Vortex Surgical Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Nov 2025 | Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25; | Device | Class II | 1 |
| 18 Dec 2023 | Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25 | Device | Class II | 1 |
All 3 events for Vortex Surgical Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.