Cardinal Health AAMI 3 RoyalSilk Scrbnur Gown Recall: Unknown Bioburden Hazard

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Recalling firmCardinal Health1350 Bridge Dr, N/A · Waukegan, IL 60085-6306

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Cardinal Health is recalling AAMI 3 RoyalSilk Scrbnur Gowns with unknown bioburden and contamination risks. This could affect health if used in medical settings where sterile conditions are critical.

Why it’s dangerous

The gowns contain unknown levels of bacteria, microorganisms, and particles that could cause infections if used in sterile medical procedures. This contamination risk is particularly concerning for surgical or critical care environments where sterility is essential.

Who’s affected

Healthcare workers and patients using these gowns in medical settings are most at risk due to potential contamination. The recall affects specific production lots from 2018-2019.

How to tell if you have this one

Check for the lot number on the gown label. For 2018 production, the month code (J=Sept, K=Oct, L=Nov, M=Dec) must be present. For 2019 production, all lots are affected.

Brand
Cardinal Health
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Look for the lot number on the gown label to determine if it's affected.

✎ GovInfoNow

Questions people ask

Are all 2019 gowns affected?

Yes, all 2019 production lots are affected due to the unknown contamination.

How can I tell if my gown is from 2018?

For 2018 production, the month code in the lot number (J=Sept, K=Oct, L=Nov, M=Dec) indicates the affected period.

Is there a fix for this issue?

The recall does not provide a fix; affected gowns should be stopped from use.

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-1010-2020 — Cardinal Health Cardinal Health

Hello,

I own a Cardinal Health that is covered by recall Z-1010-2020 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-1010-2020 (January 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1010-2020 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 recalls AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC

Recall notice