Reported Dec 22, 2021 · Ongoing

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL

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?

  • SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large
  • X-long SKU9041EL
Lot codes and dates
  • Lot Numbers
    • 20MBQ001
    • 21ABQ001
    • 21ABQ002
    • 21BBQ002
    • 21BBQ003
    • 21BBQ004
    • 21BBQ005
    • 21CBQ002
    • 21CBQ003
    • 21DBQ003
    • 21DBQ004
    • 21DBQ005
    • 21EBQ003
    • 21EBQ004
    • 21EBQ005
    • 21FBQ002
    • 21FBQ003
    • 21FBQ004
    • 21FBQ005
    • 21HBQ001
    • 21HBQ002
    • 21JBQ002
  • UDI50192253018996 (cs) 10192253018998 (ea)
Amount recalled
363,480 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, 6:19 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.