RoyalSilk Surgical Gowns: Sterility Risk in Large Size

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Contact the company & request your remedy

Recalling firmCardinal Health1270 Waukegan Rd Bldg C · Waukegan, IL 60085-6722

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

Cardinal Health is recalling RoyalSilk Large surgical gowns (SKU 9518) because the packaging seals might not stay closed properly, risking contamination during surgery. This could lead to infections if the gowns are used in sterile procedures.

Why it’s dangerous

The packaging seals on these surgical gowns may not stay closed properly, which could allow contamination. If the gowns are used in sterile procedures without proper sterility, infections could occur.

Who’s affected

Surgical staff and hospitals using the RoyalSilk Large surgical gowns (SKU 9518) with lot numbers 20MMQ001 through 21HMQ001 are most at risk. The gowns are intended for surgical use only.

How to tell if you have this one

Check for the SKU number 9518 on the gown label. Lot numbers range from 20MMQ001 to 21HMQ001. The UDI code starts with 50192253006160 or 10192253006162.

Brand
Cardinal Health
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Packaging Seal
Inspect the packaging seal for any signs of being open or damaged.

✎ GovInfoNow

Questions people ask

Are these gowns safe to use?

The recall indicates a potential risk to sterility, so they should not be used until the issue is resolved.

What lot numbers are affected?

Lot numbers 20MMQ001 through 21HMQ001 are affected.

How can I confirm if I have the recalled product?

Check the SKU number 9518 and lot numbers listed in the recall notice.

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-0375-2022 — Cardinal Health Cardinal Health

Hello,

I own a Cardinal Health that is covered by recall Z-0375-2022 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-0375-2022 (November 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0375-2022 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 RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518

Lower-risk recall