Reported Apr 9, 2025 · Ongoing
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
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 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
- Lot codes and dates
- 5400-010-008I
- UDI-DI07613154340804
- Lot Numbers2024082014; 5400-010-008ITL
20221005142023011113202301241220230417122023052212202306271420231102142024011112202210061620230116122023012712202305081220230530122023062914202311071420240129122022101733202301171220230210142023050912202306151620230703142023111312202401311220221018152023011912202302141420230512122023061614202309191420231115122024020712202210241220230123122023041212202305171320230626142023092112202311221220240212152024030612202403111220240424122024042514202407311420240801162024080913
- UDI-DI07613327359503
- Lot Numbers
214 of 214 codes
202209271220221129122023020613202304261220230904122023112814202402141420240326122022092912202211301220230207122023050512202309061220231129142024021512202404021520220930142022120112202302081220230510122023090714202311301420240216122024040414202210043220221202122023020913202305151220230913122023120114202402191220240416142022101212202212053220230221122023051616202309141420240109142024022112202404171220221021142022120533202303061420230523122023092214202401101220240222122024051312202210261220221206322023030712202305241420230927322024011214202402231220240514122022102714202212051220230308122023052516
- 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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