Cardinal Health Gel Packs: Do Not Use on Infants or Neonates

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Contact the company & request your remedy

Recalling firmCardinal Health 200, LLC3651 Birchwood Dr, N/A · Waukegan, IL 60085-8337

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Cardinal Health is recalling insulated gel packs that should not be used on infants or neonates. This recall is to prevent potential safety risks for babies under 1 year old.

Why it’s dangerous

The gel packs are designed for use on infants and neonates. However, the product should not be used on babies under 1 year due to safety concerns. This could lead to potential harm if used incorrectly.

Who’s affected

Parents and caregivers who use these gel packs on infants or neonates are affected. Infants under 1 year of age are at the highest risk.

How to tell if you have this one

Check for the product name 'Cardinal Health INSULATED GEL PACK REUSABLE, SMALL' with model number Cat. 80204A. All lots of this product are affected.

Brand
Cardinal Health
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product name and model number to confirm if it is affected.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The product should not be used on infants or neonates due to safety risks.

Is there a fix for this issue?

The official recall does not mention a fix; the product should not be used on infants or neonates.

How can I check if I have the recalled product?

Look for the product name 'Cardinal Health INSULATED GEL PACK REUSABLE, SMALL' with model number Cat. 80204A. All lots are affected.

Take action

Contact Cardinal Health

We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0189-2023 — Cardinal Health Cardinal Health

Hello,

I own a Cardinal Health that is covered by recall Z-0189-2023 from Cardinal Health.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-0189-2023 (September 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0189-2023 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.

Cardinal Health 200, LLC recalls Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A

Lower-risk recall