Reported Apr 9, 2025 · Ongoing
Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
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?
- Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
- Lot codes and dates
- 5400-020-000
- UDI-DI07613327301670
- Lot Numbers2024050814; 5400-020-000ITL
20221012142023011115202302161220230619322023101632202401153220240515122022101314202301121220230313122023062612202311023220240219142024072631202210141420230113142023031414202306281220231130342024022731202408131220221019142023011615202304241320230724332023120732202403043120240826142023010912202301181420230502122023091112202312153220240319322024082812202210121420230111152023021612202306193220231016322024011532202405151220230110152023021313202305101420230912122023121832
- UDI-DI07613327359466
- Lot Numbers
392 of 392 codes
202210191220230309142023070715202307313220230905122023101012202311083220231206122022102614202303101520230707122023080132202309071220231010142023111314202312063320221107142023032932202307113220230802322023090814202310113320231109322023120714202211081420230426142023071133202308023320230912142023101114202311133220231207122022110914202305011320230711342023080332202309131420231013142023111333202312081420221110142023050312202307113520230807322023091416202310131320231115142023120812202211111420230504122023071232202308073320230915142023101615202311163220231212322022111715202306141420230712332023080932
- 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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