Reported Apr 9, 2025 · Ongoing
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
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?
- Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
- Lot codes and dates
- 5400-020-208
- UDI-DI07613327117233
- Lot Numbers7; 5400-020-208ITL
115 of 115 codes
202209302020230116322023041321202306232020230922202023112232202403212020240524202022093021202301193220230421202023062220202309293220231124202024032820202405232020221007202023012732202304212120230731202023101220202311232020240329202024060620202210062020230130332023050320202307312120231012212023120120202404052020240607202022101320202302013220230502202023081520202310192120231130202024040420202406202020221014202023020632202305162020230815212023101920202312063220240418202024062120202210172020230220332023051720202308252020231027212023121533202404192020240704202022102120202303022020230526202023082521
- UDI-DI07613327602623
- Lot Numbers2024052333
- 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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