Use caution Medical device recall · FDA · Published February 10, 2025

Alcon Custom Pak with Non-Latex Symbol: Latex Allergy Risk

Alcon recalls custom surgical packs with a latex-free symbol that may contain latex. If you have latex sensitivity, contact Alcon for a replacement.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1293-2025Medical device Alcon ›

Use caution until it’s fixed

Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or patients with latex sensitivity come into contact with latex, an allergic reaction may occur.

Take action

Contact the company

Recalling firmAlcon Research LLC6201 South Fwy · Fort Worth, TX 76134-2099

✎ GovInfoNow plain-language explainer

Alcon is recalling custom surgical packs that mistakenly label themselves as latex-free but contain latex. This poses a risk of allergic reactions for people with latex sensitivity during surgery. Read more at govinfonow.com/recall/52929-alcon-custom-pak-with-non-latex-symbol-latex-allergy-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/52929-alcon-custom-pak-with-non-latex-symbol-latex-allergy-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1293-2025

Cite this page

“Alcon Custom Pak with Non-Latex Symbol: Latex Allergy Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52929-alcon-custom-pak-with-non-latex-symbol-latex-allergy-risk. Based on FDA recall #Z-1293-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1293-2025%22&limit=1).

The FDA announced on Feb. 10, 2025, that Alcon Research LLC is recalling Alcon Custom Pak sterile surgical procedure packs because they contain latex despite labels indicating they are latex-free. The agency said the mislabeling poses an allergic reaction risk to users or patients with latex sensitivity.

How to tell if you have it

Brand: Alcon
Product: Alcon Custom Pak with Non-Latex Symbol
Pak numbers: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09
UDI-DI: H5301ALCON1CPAK10
Units affected: 2511

The hazard

The sterile surgical procedure packs contain latex components, but the content label sealed within the transparent sterile pouch displays a symbol for a latex-free product. The FDA said if users or patients with latex sensitivity come into contact with the latex, an allergic reaction may occur.

Context

GovInfoNow's records show Alcon Research LLC has 24 other recalls on record since July 25, 2018. Other recent recalls of similar products include Alcon GenTeal Tears Eye Gel Recall (April 21, 2026), Alcon Custom Pak Sterility Risk (Nov. 24, 2025), and Alcon Recalls PRECISION1 Contact Lenses Due to Sterility Risk (Sept. 30, 2025). Other recent recalls of similar products include Stryker NICO Myriad Illumination Packs (Oct. 31, 2025), Stryker NICO Myriad Handpieces Recall (Oct. 31, 2025), and Stryker NICO BrainPath Shephard's Hook Recall (Oct. 31, 2025).

How to tell if you have this one

Check the product code on the pack (e.g., 12771-18, 18050-10). These packs have a transparent sterile pouch with a symbol indicating latex-free, but they contain latex.

Brand
Alcon
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Code
Look for the product code on the pack (e.g., 12771-18, 18050-10) to confirm if it's recalled.
Contact Alcon
If you have the recalled pack, contact Alcon directly for a replacement or instructions.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 13 states.

FDA distribution: “US Nationwide distribution in the states of AK, AR, AZ, FL, MD, MN, NC, NE, OH, PA, TX, WA, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alaska, Arizona, Arkansas, Florida, Maryland, Minnesota, Nebraska, North Carolina, Ohio, Pennsylvania, Texas, Washington, Wisconsin.

Recall timeline

FDA published this recall 30 days after the firm started it.

Feb 10, 2025Firm started the recall
Mar 6, 2025FDA classified it Class II
Mar 12, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/52929-alcon-custom-pak-with-non-latex-symbol-latex-allergy-risk">Alcon Custom Pak with Non-Latex Symbol: Latex Allergy Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1293-2025 (February 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1293-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.