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Lower risk Medical device recall · FDA · Published September 7, 2023

Alcon Custom-Pak Surgical Packs Labeled Latex-Free But Contain Latex

Alcon recalls surgical procedure packs labeled 'latex free' that actually contain latex gloves. This could cause allergic reactions in sensitive users. Check product details to see if you have the affected items.

🇺🇸 FDA recall #Z-0260-2024Medical deviceAlcon ›
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Contact the company

Recalling firmAlcon Research, LLC9965 Buffalo Speedway · Houston, TX 77054-1309
✎ GovInfoNow plain-language explainer

What happened, in plain English

Alcon is recalling surgical procedure packs labeled as 'latex free' that actually contain latex gloves. This poses a risk of allergic reactions for people sensitive to latex. Read more at govinfonow.com/recall/57362-alcon-custom-pak-surgical-packs-labeled-latex-free-but-contain.

Source Summary by GovInfoNow · govinfonow.com/recall/57362-alcon-custom-pak-surgical-packs-labeled-latex-free-but-contain · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0260-2024

Cite this page

“Alcon Custom-Pak Surgical Packs Labeled Latex-Free But Contain Latex.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/57362-alcon-custom-pak-surgical-packs-labeled-latex-free-but-contain. Based on FDA recall #Z-0260-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0260-2024%22&limit=1).

Why it’s dangerous

The packs are labeled 'latex free' but contain latex gloves. This can cause allergic reactions in individuals sensitive to latex, which may lead to skin irritation or more severe reactions.

Who’s affected

People who use these surgical packs for eye procedures, especially those with latex allergies. Medical professionals and patients undergoing cataract surgery are most at risk.

How to tell if you have this one

Check for the product name 'Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09' with lot number 160NMU. These were sold near Virginia Eye Surgery Centers starting in 2023.

  • Brand
    Alcon
  • Product
    Alcon Research, LLC recalls Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the product name and lot number on the packaging to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed in Virginia.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “US: VA OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Virginia.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Sep 7, 202312. FDA classified it Class II: Nov 7, 202323. Published in FDA’s Enforcement Report: Nov 15, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

Do I need to stop using these packs immediately?

The recall does not require immediate stopping; you can check if your pack is affected before taking action.

Are there any risks to people without latex allergies?

No significant risk for people without latex allergies, as the hazard is specific to latex-sensitive individuals.

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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-0260-2024 (September 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0260-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA