Cardinal Health Gel Pack Recall: Not for Infants or Neonates

Take action

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 due to a safety risk for babies under 1 year old.

Why it’s dangerous

The gel packs are designed for use on children over 1 year old. Using them on infants or neonates could cause harm due to their small size and developing bodies.

Who’s affected

Parents and caregivers who use these gel packs on infants or neonates are at risk. The product is intended for use on children over 1 year old.

How to tell if you have this one

The product is labeled as 'Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 8: 80104'. All lots are affected.

Brand
Cardinal Health
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the product name and model number 'Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104' on the item.

✎ GovInfoNow

Questions people ask

Is this product safe for babies under 1 year?

No, this product is not safe for use on infants or neonates. It should only be used on children over 1 year old.

What should I do if I have this product?

The recall does not specify a remedy, so you can safely continue using it if it's not for infants or neonates.

Why is this product being recalled?

The product is being recalled because it should not be used on infants or neonates due to safety concerns.

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-0188-2023 — Cardinal Health Cardinal Health

Hello,

I own a Cardinal Health that is covered by recall Z-0188-2023 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-0188-2023 (September 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0188-2023 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.

Cardinal Health 200, LLC recalls Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104

Lower-risk recall