Vortex Surgical Recalls Lindsell Sutured IOL Markers Over Sterility Concerns

Source: FDA · Worldwide

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Vortex Surgical Inc. is recalling nearly 15,000 Lindsell Sutured IOL Markers due to compromised packaging seals that could lead to patient infections.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on February 19, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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What Happened

Vortex Surgical Inc. has initiated a voluntary recall of the Lindsell Sutured IOL Marker (Scleral Marker) due to a potential defect in the product's packaging. The firm discovered that there may be voids in the seal of the Tyvek pouches used for the devices. A compromised sterile barrier increases the risk of bioburden contamination, which could lead to serious infections in patients.

Which Products Are Affected

The recall affects the following medical device:

  • Product Name: Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
  • Recall Number: Z-1256-2026
  • Lot Number: 2408035
  • UDI Numbers: Pouch UDI 810123483655; Box UDI 810123483662
  • Quantity: 14,789 units total (8,651 in the U.S.; 6,138 internationally)

The product was distributed worldwide, including the following U.S. states: 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, and VA.

What You Should Do

Healthcare providers and facilities should immediately check their inventory for the affected lot number (2408035). Affected products should be quarantined and not used in surgical procedures. Vortex Surgical Inc. notified customers of the issue via a notification letter. For questions regarding returns or replacements, contact Vortex Surgical Inc. at 4 Research Park Dr Ste 124, Saint Charles, MO 63304.

Why This Matters

Maintaining a sterile barrier is critical for surgical instruments. Any breach in packaging integrity can introduce bacteria or other contaminants, posing a significant health risk to patients undergoing ophthalmic procedures.

Source

Information provided by the FDA.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Vortex Surgical Inc. is recalling nearly 15,000 Lindsell Sutured IOL Markers due to compromised packaging seals that could lead to patient infections.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Worldwide. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.