Reported Apr 9, 2025 · Ongoing
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
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 Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
- Lot codes and dates
- 5400-020-100
- UDI-DI07613327301656
- Lot Numbers2022101016 2023021716 2023062115 2023082113 2024022114; 5400-020-100ITL
- UDI-DI07613327359497
- Lot Numbers
202302171520231002142023102315202401241420240226152024041015202405211420240827132023072513202310051520231026152024012914202403051520240417142024052415202308211420231010152023111515202402011720240308152024042214202406041220230829152023101312202401081320240213152024031314202405071320240729122023092532202310181520240111152024021615202404051520240514142024081415
- 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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