Reported Jan 1, 2020 · Ongoing

Lamicel 20PK 5MM INTL

Medtronic Xomed, Inc.

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: Medtronic Xomed, Inc. · 6743 Southpoint Dr N · Jacksonville, FL · 32216-6218

Is this the product you have?

  • Lamicel 20PK 5MM INTL
Lot codes and dates
  • UDI
    • 20885074749055
    • SPONGE 2203-501EX LAMICEL 20PK 5MM INTL
    • 2203-501EX
    • Lots 9642542
    • 9657414
    • 9657415
    • 9657416
    • 9677915
    • 9707331
    • 9707338
    • 9707334
    • 9712918
Amount recalled
307 packs; 6140 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Why it was recalled

Routine sterilization dose does not meet the required Sterility Assurance Level.

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, 4:47 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.