Reported Jul 24, 2024 · Ongoing

SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963

Ethicon Sarl, a Johnson & Johnson Company

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: Ethicon Sarl, a Johnson & Johnson Company · rue du Puits-Godet 20 · Neuchatel · N/A

Is this the product you have?

  • SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM)
  • Product Number1963
Lot codes and dates
  • Product Number1963
  • UDI/DI
    • 10705031003132 (primary)
    • 20705031003139 (box of 10)
  • Lot numbers
Amount recalled
39,010 units (All US)

This recall covers 2 products

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

Where it was sold

  • Nationwide

Why it was recalled

Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.

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

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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, 6:54 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.