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FDA recall, , Moderate risk

Vortex Surgical Ophthalmic Surgical Instruments

Volk Single Use Vitrectomy Lenses may have voids in the seal of Tyvek pouches, which could lead to infection.

Summary by Recall Canary from the FDA notice

What happened

Vortex Surgical is recalling 13 products.

More sterility problem recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is your kit affected?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Vortex Surgical I2 Injection Kit, VS0500

    Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.

    Rest of the reason

    A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

    UDI-DI
    • 810123480920
    • 810123481330
    Lot code
    • 2411012

  2. 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

    Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.

    Rest of the reason

    A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

    UDI-DI
    • 810123482917
    • 810123482924
    • 810123482429
    • 810123482443
    • 810123482412
    • 810123482436
    Lot code
    • 2410055
    • 25GA
    • 2411028
    • 2410057

  3. Rumex Disposable Diamond Dusted ILM Elevator, 12-7523

    Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.

    Rest of the reason

    A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

    UDI-DI
    • 5060720920298
    Lot code
    • 2411033

  4. Vortex Surgical TID Pharos Illuminated Depressor, VS0801B

    Reason: XXX

    UDI-DI
    • 810123481309
    • 810123481712
    Lot code
    • 2403027R

  5. Product details

    Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.

    Rest of the reason

    A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

    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 OS4 Intuitive Exendable VK401327

    UDI-DI
    • 810123483716
    • 810123483792
    • 810123483730
    • 810123483815
    • 810123483761
    • 810123483846
    • 810123483723
    • 810123483808
    • 810123483747
    • 810123483822
    • 810123483778
    • 810123483853
    • 810123483785
    • 810123483860
    Lot code
    • 2410031
    • 23G
    • OS4
    • 2410034
    • 2410033
    • 25G
    • 2410032
    • 2410058
    • 2411022
    • 2410035
    • 2412025
    • 27G
    • 2411021

  6. 25GA Subretinal Injection Cannula VS0220.25

    Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.

    Rest of the reason

    A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

    UDI-DI
    • 810123480418
    • 810123480692
    Lot code
    • 2410043

  7. Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker

    Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.

    Rest of the reason

    A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

    UDI-DI
    • 810123483655
    • 810123483662
    Lot code
    • 2408035

  8. Product details

    Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.

    Rest of the reason

    A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

    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

    UDI-DI
    • 810123480036
    • 810123480180
    • 810123480043
    • 810123480197
    • 810123480111
    • 810123480265
    • 810123480098
    • 810123480241
    • 810123480135
    • 810123480289
    • 810123480012
    • 810123480166
    Lot code
    • 2411027
    • 25GA
    • 2411026
    • 2411024
    • 2411031
    • 2411025
    • 2410029
    • 2411023
    • 2411030

  9. Product details

    Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.

    Rest of the reason

    A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

    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 Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Cannula-Bulk VS0200.25B 15. 27GA Soft Tip Cannula VS0200.27

    UDI-DI
    • 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
    Lot code
    • 2411009
    • 25GA
    • ACTU8
    • 2410051
    • 2410021
    • 2410053
    • 2411006
    • 2410059
    • 2410050
    • 2411011
    • 2411003
    • 2410060
    • 27GA
    • 2410054
    • 23GA
    • 2410037
    • 0.5mm
    • 2411032
    • 2410039
    • 2410041
    • 2410042
    • 2411018
    • 2410040
    • 2412026

  10. Tecfen Retractable Membrane Polisher, QTPR1267-23

    Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.

    Rest of the reason

    A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

    UDI-DI
    • 817618024508
    Lot code
    • 2411013

  11. Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD

    Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.

    Rest of the reason

    A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

    UDI-DI
    • 810123482290
    • 810123482306
    • 810123482825
    • 810123482832
    Lot code
    • 2410036
    • 2411020
    • 2411019

  12. Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27

    Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.

    Rest of the reason

    A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

    UDI-DI
    • 810123480470
    • 810123480753
    • 810123480517
    • 810123480791
    Lot code
    • 2411017
    • 2411016

  13. Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25

    Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.

    Rest of the reason

    A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

    UDI-DI
    • 810123480456
    • 810123480739
    Lot code
    • 2410044

Recall details

Company began the recall
Sold in

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 countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.

Company
Vortex Surgical Inc.Saint Charles, Missouri
Hazard
Sterility problem
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
98255
Recall numbers
Z-1244-2026 to Z-1256-2026

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. In FDA's weekly enforcement report

  4. Listed on Recall Canary

Other sterility problem recalls

See all: Other sterility problem recalls

Summary by Recall Canary, written with AI · summary updated Oct 23, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)