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Lower risk Medical device recall · FDA · Published September 28, 2022

Cardinal Health GEL PACK Reusable Small: Not for Infants or Neonates

Cardinal Health recalls reusable small gel packs for infants and neonates. The product should not be used on infants or neonates due to safety concerns.

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

🇺🇸 FDA recall #Z-0186-2023Medical deviceCardinal Health ›
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Contact the company

Recalling firmCardinal Health 200, LLC3651 Birchwood Dr · Waukegan, IL 60085-8337
✎ GovInfoNow plain-language explainer

Cardinal Health is recalling reusable small gel packs because they should not be used on infants or neonates. This is a safety precaution to prevent potential harm to young children. Read more at govinfonow.com/recall/59994-cardinal-health-gel-pack-reusable-small-not-for-infants-or.

Source Summary by GovInfoNow · govinfonow.com/recall/59994-cardinal-health-gel-pack-reusable-small-not-for-infants-or · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0186-2023

Cite this page

“Cardinal Health GEL PACK Reusable Small: Not for Infants or Neonates.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59994-cardinal-health-gel-pack-reusable-small-not-for-infants-or. Based on FDA recall #Z-0186-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0186-2023%22&limit=1).

Cardinal Health 200, LLC is recalling Cardinal Health GEL PACK REUSABLE, SMALL (Cat. 70204) because the product should not be used on infants or neonates, according to the FDA. The Food and Drug Administration announced the Class II recall on September 28, 2022.

How to tell if you have it

  • Brand: Cardinal Health
  • Product: GEL PACK REUSABLE, SMALL
  • Catalog Number: Cat. 70204
  • Lots: All lots
  • Quantity: 409,738 units

The hazard

The recall addresses the risk of using the gel packs on infants or neonates. The company will add a caution statement to the labeling clarifying that the product is not for use on this population.

Context

GovInfoNow's records show Cardinal Health 200, LLC has issued 58 other recalls since June 27, 2017. Recent actions include August 18, 2026, for Presource Packs containing Stryker StrykeFlow PS and AHTO tube sets due to potential fluid leakage, and August 10, 2026, for Presource Convenience Kits with potentially contaminated applicators. Other recent recalls of similar products include the March 9, 2026, LSL Healthcare Infant Central Line Dressing Kit Recall involving non-sterile alcohol pads.

How to tell if you have this one

Check for the product name 'Cardinal Health GEL PACK REUSABLE, SMALL' with model number Cat. 70204. All lots of this product are included in the recall.

  • Brand
    Cardinal Health
  • Category
    Medical device
FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    nationwide and Canada
Recall numberProduct, codes & lotsQuantity
Z-0185-2023Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115; All lots1915308 units
Z-0186-2023Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204; All lots409738 units
Z-0187-2023Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304; All lots567475 units
Z-0188-2023Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104; All lots1209260 units
Z-0189-2023Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A; All lots499997 units
Z-0190-2023Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A; All lots649213 units
Z-0191-2023Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600; All lots414194 units
Z-0192-2023Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A; UDI/DI (01)30888499004898, All lots129412 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the model number Cat. 70204 on the product label to confirm it is part of the recall.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “nationwide and Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 49 days after the firm started it.

1. Firm started the recall: Sep 28, 202212. FDA classified it Class II: Nov 7, 202223. Published in FDA’s Enforcement Report: Nov 16, 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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Other Cardinal Health recalls

Cardinal Health 200, LLC recalls Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive,
March 2, 2026Cardinal Health 200, LLC recalls Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
September 25, 2024

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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-0186-2023 (September 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0186-2023 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