Reported Apr 9, 2025 · Ongoing
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
Stryker Corporation
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: Stryker Corporation · 1941 Stryker Way · Portage, MI · 49002-9711
Is this the product you have?
- Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
- Lot codes and dates
- 5400-010-004
- UDI-DI07613154340798
- Lot Numbers2024082216; 5400-010-004ITL
202210181420230214122023082413202402291520221114142023051712202309011420221024132023022133202309061320240319152023011013202305241520231103152022111413202305091320230919122024032215202301191320230616152023112314202301161320230512132023103115202404021420230201132023062132202401191220230124132023071713202311081220240529152023020333202306261520240208132023012713202308081220231120182024062412202302061220230629152024080117202302091220230811122024011613202408091220230504142023070433
- UDI-DI07613327359435
- Lot Numbers
202211141420230517122023090114202301101320230524152023110315202301191320230616152023112314202302011320230621322024011912202302033320230626152024020813202302061220230629152024080117202305041420230704332024082216
- Amount recalled
- 182,344 total units
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
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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