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Lower risk Medical device recall · FDA · Published June 9, 2022

Alcon Custom Pak Surgical Packs Contain Latex Gloves - Recall

Alcon recalls surgical procedure packs that include latex gloves, which are supposed to have non-latex gloves. Affected packs were sold to eye surgery centers in the US. Consumers should check product labels for specific batch numbers.

🇺🇸 FDA recall #Z-1373-2022Medical deviceAlcon ›
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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 that accidentally include latex gloves instead of non-latex gloves. This could cause allergic reactions in people sensitive to latex, especially during surgeries where gloves are critical. Read more at govinfonow.com/recall/60527-alcon-custom-pak-surgical-packs-contain-latex-gloves-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/60527-alcon-custom-pak-surgical-packs-contain-latex-gloves-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1373-2022

Cite this page

“Alcon Custom Pak Surgical Packs Contain Latex Gloves - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60527-alcon-custom-pak-surgical-packs-contain-latex-gloves-recall. Based on FDA recall #Z-1373-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1373-2022%22&limit=1).

Why it’s dangerous

The packs are supposed to include non-latex gloves, but some contain latex gloves. Latex allergies can cause severe reactions, including anaphylaxis, during medical procedures where gloves are essential.

Who’s affected

Eye surgery centers and medical professionals who used the recalled packs. Those with latex allergies are at higher risk of allergic reactions.

How to tell if you have this one

Check the product label for batch numbers like 2519351H or 14HDFF. The packs were sold to eye surgery centers in the US starting from specific dates indicated in the batch codes.

  • Brand
    Alcon
  • Product
    Alcon Research, LLC recalls Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for batch numbers such as 2519351H or 14HDFF on the pack.

Where it went and when

Where it was distributed

Distributed in 4 states.

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: yesNYRhode 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: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew 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: “U.S.: AZ, CA, MO, and NY O.U.S.: None” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Missouri, New York.

Recall timeline

FDA published this recall 41 days after the firm started it.

1. Firm started the recall: Jun 9, 202212. FDA classified it Class II: Jul 12, 202223. Published in FDA’s Enforcement Report: Jul 20, 202232022
  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.

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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-1373-2022 (June 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1373-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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