Cardinal Health Gel Pack Extra Small: Not for 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 extra small reusable gel packs because they should not be used on infants or neonates. This is a safety precaution to prevent potential harm to babies.

Why it’s dangerous

The gel packs are designed for use on infants and neonates. However, the product should not be used on these age groups 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 and neonates are at the highest risk due to their small size and developing bodies.

How to tell if you have this one

Check for the product name 'Cardinal Health GEL PACK REUSABLE, EXTRA SMALL' and the model number 'Cat. 611:15'. 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 part of the recall.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

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

What should I do if I have this product?

The official recall notice does not specify a remedy or action steps for affected products.

Is there a risk of serious injury from using this product on infants?

The recall states the product should not be used on infants or neonates, but does not specify the risk of serious injury.

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-0185-2023 — Cardinal Health Cardinal Health

Hello,

I own a Cardinal Health that is covered by recall Z-0185-2023 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-0185-2023 (September 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0185-2023 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 GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115

Lower-risk recall