Reported Jun 26, 2024 · Ongoing

MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an…

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 (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable
  • material is indicated PRODUCT CODE
    • Y315H
    • Y345H
    • Y359H
    • Y398H
    • Y416H
    • Y417H
    • Y426H
    • Y427H
    • Y935H
    • Y936H
    • Y945H
Lot codes and dates
  • GTINGTIN
    • 10705031058729
    • 10705031058897
    • 10705031059047
    • 10705031059092
    • 10705031059122
    • 30705031059133
    • 10705031112674
    • 10705031059146
    • 10705031059153
    • 10705031059245
    • 10705031059894
    • 10705031059917
    • 10705031059962
    PRODUCT CODE PRODUCT LOTS Y315H UAMQCX Y345H UBMCAJ Y359H UBMHQS Y398H UAMLMU UAMPJB UAMMXQ UBMJPB UBMQQR Y416H UAMLQM UAMLKM UAMRMZ Y417H UCMEDU Y426H UAMKCL UAMKHE UAMPQS UBMJTE Y427H UAMLXX UAMMJR UAMPSC Y935H UBMCAA UBMDKJ UBMDKC UBMHDD Y936H UBMJQM Y945H UAMKCD
Amount recalled
306000 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, 4:51 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.