Reported Feb 11, 2026 · Ongoing

25GA Subretinal Injection Cannula VS0220.25

Vortex Surgical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

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

Is this the product you have?

  • 25GA Subretinal Injection Cannula VS0220.25
Lot codes and dates
  • Pouch UDI 810123480418 Box UDI 810123480692 Lot 2410043
Amount recalled
14,789 (8651 US; 6138 OUS)

This recall covers 13 products

The agency filed one notice per product. You are reading one of them; the other 12 are below.

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:40 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.