Vortex Surgical Ophthalmic Instruments Recalled for Sterility Failure

Agency Publication Date: February 4, 2026

Summary

Vortex Surgical Inc. is recalling approximately 14,789 units of various ophthalmic surgical instruments, including laser probes, forceps, cannulas, and vitrectomy lenses. The recall was initiated because the Tyvek pouches used for packaging may have gaps or voids in the sterile seal. These tools are used in delicate eye surgeries, and a compromised sterile barrier could lead to serious infections and surgical complications.

Risk

Gaps in the packaging seal allow bacteria and other contaminants to enter the pouch, compromising the sterility of the surgical tools. Use of these non-sterile instruments during eye surgery can cause bioburden contamination, potentially leading to severe internal eye infections.

What You Should Do

Stop using the recalled surgical instruments immediately and remove them from your active inventory.
Identify affected products by checking the catalog numbers and lot numbers on the device pouch or box labels. See the Affected Products section below for the full list of affected codes.
Contact Vortex Surgical Inc. or your distributor to arrange for the return, replacement, or correction of the affected units.
If you have health concerns or believe these instruments were used in a recent procedure, contact your healthcare provider or surgical facility supervisor.
Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Volk Single Use Vitrectomy Lenses

Variants: Flat Vitrectomy Lens, Volk Magnifying Lens

Model / REF:

VFD

VMD

Lot Numbers:

2410036

2411020

2411019

UDI:

810123482290

810123482306

810123482825

810123482832

Recall #: Z-1244-2026

Product: Vortex Surgical Laser Probes

Variants: 23GA Laser Probe Curved, 25GA Laser Probe Curved, 25GA Laser Probe Flex-Tip, 25GA Laser Probe Illuminated Curved, 25GA Laser Probe MaxReach, 25GA Laser Probe Straight

Model / REF:

VS0120.23

VS0120.25

VS0130.25

VS0125.25B

VS0140.25

VS0110.25

Lot Numbers:

2411027

2411026

2411024

2411031

2411025

2410029

2411023

2411030

UDI:

810123480036

810123480180

810123480043

810123480197

810123480111

810123480265

810123480098

810123480241

810123480135

810123480289

810123480012

810123480166

Recall #: Z-1245-2026

Product: Oertli Laser Probes

Variants: 23G Laser Probe OS4 Flex-Tip, 23G Laser Probe OS4 Illuminated Flex-Tip, 23G Laser Probe OS4 Intuitive Exendable, 25G Laser Probe OS4 Flex-Tip, 25G Laser Probe OS4 Illuminated Flex-Tip, 25G Laser Probe OS4 Intuitive Exendable, 27G Laser Probe OS4 Intuitive Exendable

Model / REF:

VK401113

VK401213

VK401323

VK401115

VK401215

VK401325

VK401327

Lot Numbers:

2410031

2410034

2410033

2410032

2410058

2411022

2410035

2412025

2411021

UDI:

810123483716

810123483792

810123483730

810123483815

810123483761

810123483846

810123483723

810123483808

810123483747

810123483822

810123483778

810123483853

810123483785

810123483860

Recall #: Z-1246-2026

Product: Vortex Disposable Forceps and Cannula

Variants: 23GA ACTU8 Forceps Adaptive, 25GA ACTU8 Forceps Adaptive, 25GA ACTU8 Forceps ILM, 25GA ACTU8 Forceps ILM - Myopic, 25GA ACTU8 Forceps Pro-Grip, 25GA ACTU8 Talon Forceps ILM, 25GA ACTU8 Talon Forceps Pro-Grip, 27GA ACTU8 Forceps ILM, 23GA Soft Tip Cannula, 23GA Soft Tip Cannula - 0.5mm, 25GA Soft Tip Cannula, 25GA Soft Tip Cannula - 0.5mm, 25GA Soft Tip Cannula - 0.5mm - Bulk, 25GA Soft Tip Cannula - Bulk, 27GA Soft Tip Cannula

Model / REF:

VS0740.23

VS0740.25

VS0744.25

VS0744.25-35

VS0713.25

VS0752.25

VS0751.25

VS0744.27

VS0200.23

VS0205.23

VS0200.25

VS0205.25

VS0205.25B

VS0200.25B

VS0200.27

Lot Numbers:

2411009

2410051

2410021

2410053

2411006

2410059

2410050

2411011

2411003

2410060

2410054

2410037

2411032

2410039

2410041

2410042

2411018

2410040

2412026

UDI:

810123481125

810123481538

810123481132

810123481545

810123481231

810123481644

810123481248

810123481651

810123481101

810123481514

810123481835

810123481859

810123482375

810123482405

810123481255

810123481668

810123480302

810123480562

810123480388

810123480661

810123480319

810123480586

810123480395

810123480678

810123481927

810123480593

810123480326

810123480609

Recall #: Z-1247-2026

Product: 25GA Subretinal Injection Cannula

Model / REF:

VS0220.25

Lot Numbers:

2410043

UDI:

810123480418

810123480692

Recall #: Z-1248-2026

Product: Convenience Kits

Variants: 25GA Convenience Kit - FNX, 25GA Convenience Kit - FXX, 25GA Convenience Kit - XES

Model / REF:

VS0644.25-FNX

VS0644.25-FXX

VS0644.25-XES

Lot Numbers:

2410055

2411028

2410057

UDI:

810123482917

810123482924

810123482429

810123482443

810123482412

810123482436

Recall #: Z-1249-2026

Product: Vortex Surgical 25GA I.D.D. Internal Delivery Device

Model / REF:

VS0250.25

Lot Numbers:

2410044

UDI:

810123480456

810123480739

Recall #: Z-1250-2026

Product: Tecfen Retractable Membrane Polisher

Model / REF:

QTPR1267-23

Lot Numbers:

2411013

UDI:

817618024508

Recall #: Z-1251-2026

Product: Vortex Surgical I2 Injection Kit

Model / REF:

VS0500

Lot Numbers:

2411012

UDI:

810123480920

810123481330

Recall #: Z-1252-2026

Product: Rumex Disposable Diamond Dusted ILM Elevator

Model / REF:

12-7523

Lot Numbers:

2411033

UDI:

5060720920298

Recall #: Z-1253-2026

Product: Vortex Surgical TID Pharos Illuminated Depressor

Model / REF:

VS0801B

Lot Numbers:

2403027R

UDI:

810123481309

810123481712

Recall #: Z-1254-2026

Product: Vortex Surgical Backflush Instruments

Variants: 25GA Backflush, 25GA Backflush Retractable

Model / REF:

VS0270.25

VS0275.27

Lot Numbers:

2411017

2411016

UDI:

810123480470

810123480753

810123480517

810123480791

Recall #: Z-1255-2026

Product: Vortex Surgical Lindsell Sutured IOL Marker

Variants: Scleral Marker

Model / REF:

VS0390

Lot Numbers:

2408035

UDI:

810123483655

810123483662

Recall #: Z-1256-2026

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98255

Status: Active

Manufacturer: Vortex Surgical Inc.

Sold By: Authorized Medical Distributors; Direct Sales to Hospitals and Surgical Centers

Manufactured In: United States

Units Affected: 13 products (14,789 (8651 US; 6138 OUS))

Distributed To: Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Washington, Wisconsin, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Stop using the recalled surgical instruments immediately and remove them from your active inventory.

Identify affected products by checking the catalog numbers and lot numbers on the device pouch or box labels. See the Affected Products section below for the full list of affected codes.

Contact Vortex Surgical Inc. or your distributor to arrange for the return, replacement, or correction of the affected units.

If you have health concerns or believe these instruments were used in a recent procedure, contact your healthcare provider or surgical facility supervisor.

Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Affected Products

Product: Volk Single Use Vitrectomy Lenses

Variants: Flat Vitrectomy Lens, Volk Magnifying Lens

Model / REF:

VFD

VMD

Lot Numbers:

2410036

2411020

2411019

UDI:

810123482290

810123482306

810123482825

810123482832

Recall #: Z-1244-2026

Product: Vortex Surgical Laser Probes

Variants: 23GA Laser Probe Curved, 25GA Laser Probe Curved, 25GA Laser Probe Flex-Tip, 25GA Laser Probe Illuminated Curved, 25GA Laser Probe MaxReach, 25GA Laser Probe Straight

Model / REF:

VS0120.23

VS0120.25

VS0130.25

VS0125.25B

VS0140.25

VS0110.25

Lot Numbers:

2411027

2411026

2411024

2411031

2411025

2410029

2411023

2411030

UDI:

810123480036

810123480180

810123480043

810123480197

810123480111

810123480265

810123480098

810123480241

810123480135

810123480289

810123480012

810123480166

Recall #: Z-1245-2026

Product: Oertli Laser Probes

Model / REF:

VK401113

VK401213

VK401323

VK401115

VK401215

VK401325

VK401327

Lot Numbers:

2410031

2410034

2410033

2410032

2410058

2411022

2410035

2412025

2411021

UDI:

810123483716

810123483792

810123483730

810123483815

810123483761

810123483846

810123483723

810123483808

810123483747

810123483822

810123483778

810123483853

810123483785

810123483860

Recall #: Z-1246-2026

Product: Vortex Disposable Forceps and Cannula

Model / REF:

VS0740.23

VS0740.25

VS0744.25

VS0744.25-35

VS0713.25

VS0752.25

VS0751.25

VS0744.27

VS0200.23

VS0205.23

VS0200.25

VS0205.25

VS0205.25B

VS0200.25B

VS0200.27

Lot Numbers:

2411009

2410051

2410021

2410053

2411006

2410059

2410050

2411011

2411003

2410060

2410054

2410037

2411032

2410039

2410041

2410042

2411018

2410040

2412026

UDI:

810123481125

810123481538

810123481132

810123481545

810123481231

810123481644

810123481248

810123481651

810123481101

810123481514

810123481835

810123481859

810123482375

810123482405

810123481255

810123481668

810123480302

810123480562

810123480388

810123480661

810123480319

810123480586

810123480395

810123480678

810123481927

810123480593

810123480326

810123480609

Recall #: Z-1247-2026

Product: 25GA Subretinal Injection Cannula

Model / REF:

VS0220.25

Lot Numbers:

2410043

UDI:

810123480418

810123480692

Recall #: Z-1248-2026

Product: Convenience Kits

Variants: 25GA Convenience Kit - FNX, 25GA Convenience Kit - FXX, 25GA Convenience Kit - XES

Model / REF:

VS0644.25-FNX

VS0644.25-FXX

VS0644.25-XES

Lot Numbers:

2410055

2411028

2410057

UDI:

810123482917

810123482924

810123482429

810123482443

810123482412

810123482436

Recall #: Z-1249-2026

Product: Vortex Surgical 25GA I.D.D. Internal Delivery Device

Model / REF:

VS0250.25

Lot Numbers:

2410044

UDI:

810123480456

810123480739

Recall #: Z-1250-2026

Product: Tecfen Retractable Membrane Polisher

Model / REF:

QTPR1267-23

Lot Numbers:

2411013

UDI:

817618024508

Recall #: Z-1251-2026

Product: Vortex Surgical I2 Injection Kit

Model / REF:

VS0500

Lot Numbers:

2411012

UDI:

810123480920

810123481330

Recall #: Z-1252-2026

Product: Rumex Disposable Diamond Dusted ILM Elevator

Model / REF:

12-7523

Lot Numbers:

2411033

UDI:

5060720920298

Recall #: Z-1253-2026

Product: Vortex Surgical TID Pharos Illuminated Depressor

Model / REF:

VS0801B

Lot Numbers:

2403027R

UDI:

810123481309

810123481712

Recall #: Z-1254-2026

Product: Vortex Surgical Backflush Instruments

Variants: 25GA Backflush, 25GA Backflush Retractable

Model / REF:

VS0270.25

VS0275.27

Lot Numbers:

2411017

2411016

UDI:

810123480470

810123480753

810123480517

810123480791

Recall #: Z-1255-2026

Product: Vortex Surgical Lindsell Sutured IOL Marker

Variants: Scleral Marker

Model / REF:

VS0390

Lot Numbers:

2408035

UDI:

810123483655

810123483662

Recall #: Z-1256-2026

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98255

Status: Active

Manufacturer: Vortex Surgical Inc.

Sold By: Authorized Medical Distributors; Direct Sales to Hospitals and Surgical Centers

Manufactured In: United States

Units Affected: 13 products (14,789 (8651 US; 6138 OUS))