Reported Jun 26, 2024 · Ongoing

MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or…

Ethicon, 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: Ethicon, Inc. · 1000 Route 202 · Raritan, NJ · 08869-1425

Is this the product you have?

  • MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated
  • PRODUCT CODE
    • MCP266H13
    • MCP3200H16
    • MCP3212H16
    • MCP3213H16
    • MCP340H13
    • MCP345H13
    • MCP416H14
    • MCP417H14
    • MCP426H13
    • MCP427H13
    • MCP4423H16
    • MCP4424H14
    • MCP442H14
    • MCP496H16
    • MCP497H16
    • MCP604H13
    • MCP936H13
    • MCP945H14
    • MCPB346H13
Lot codes and dates
  • GTIN
    • 10705031046337
    • 10705031121393
    • 10705031121423
    • 10705031121430
    • 10705031046405
    • 10705031046429
    • 10705031046481
    • 10705031046498
    • 10705031046504
    • 10705031046511
    • 10705031121997
    • 10705031148116
    • 10705031122000
    • 10705031122314
    • 10705031122338
    • 10705031046634
    • 10705031046757
    • 10705031046795
    • 10705031046863
    Product Code Lot Code MCP266H UAMMCX MCP340H UAMQUZ MCP416H UBMHLB MCP417H UBMLKK MCP426H UAMLDQ UAMRSL UAMRUM UAMRUU UAMRMR UAMRUK UAMRMB MCP427H UAMLRK UAMMCH UAMLTR UAMKTS UAMKQL UAMREE MCP604H UAMLQE MCP936H UBMDQM UBMDPZ UBMEXS UBMQAR UBMEQX UBMKZA UBMLDR MCP945H UAMRKQ MCPB346H UAMQZB
Amount recalled
287892 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Why it was recalled

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

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, 4:50 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.