Class II U.S. Food and Drug Administration

Vortex Surgical Inc. 25GA Subretinal Injection Cannula VS0220.25 recall: There may be voids located in the seal of Tyvek pouches associated

Recall published 9 months ago

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.

The hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

What the notice says: 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.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-1248-2026
Published
February 11, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Vortex Surgical Inc.
Product type
Medical devices
Units affected
14,789 (8651 US; 6138 OUS)
Distribution
Nationwide
Made in
United States
Lot / code info
Pouch UDI 810123480418 Box UDI 810123480692 Lot 2410043
UPC codes
810123480418, 810123480692

Products covered by this recall

25GA Subretinal Injection Cannula VS0220.25

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 810123480418
  • 810123480692

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2410043 — 14
  • 789

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Vortex Surgical Inc. — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  3. Report any infection or reaction you think the product caused to FDA MedWatch.
  4. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Vortex Surgical Inc. — 4 Research Park Dr Ste 124, Saint Charles, MO, 63304-5639

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Vortex Surgical Inc. medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 810123480418, 810123480692; lot code 2410043 — 14, 789. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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