Reported Jan 1, 2020 · Ongoing
Lamicel 20PK 3MM INTL Cervical dilator
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 3MM INTL Cervical dilator
- Lot codes and dates
- UDI
20885074749024SPONGE 2202-501EX LAMICEL 20PK 3MM INTL2202-501EXLots 96466059651239965124096512459667694966769796677569669946968612796861289688076969334696933479693339977526497997059799708981117498126169819177981951398195169851438
- UDI
- Amount recalled
- 29320 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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