Reported Dec 22, 2021 · Ongoing

RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518

Cardinal Health

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cardinal Health · 1270 Waukegan Rd Bldg C · Waukegan, IL · 60085-6722

Is this the product you have?

  • RoyalSilk
  • Non-Reinforced Surgical Gowns Large SKU9518
Lot codes and dates
  • Lot Numbers
    • 20MMQ001
    • 20MMQ002
    • 20MMQ003
    • 21AMQ001
    • 21AMQ002
    • 21AMQ003
    • 21AMQ004
    • 21BMQ001
    • 21BMQ002
    • 21CMQ001
    • 21CMQ002
    • 21CMQ003
    • 21EMQ001
    • 21EMQ002
    • 21FMQ001
    • 21FMQ002
    • 21HMQ001
  • UDI50192253006160 (cs) 10192253006162 (ea)
Amount recalled
364,481 units

This recall covers 11 products

The agency filed one notice per product. You are reading one of them; the other 10 are below.

Where it was sold

  • Nationwide

Why it was recalled

Potential for open packaging seals compromising the sterility of the surgical gowns

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:29 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.