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Stryker Corporation recalls Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
Recalled April 9, 2025 · FDA recall Z-1475-2025 · Stryker
Hazard
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. · FDA Class II
Units
182,344 total units
Sold at
US Nationwide distribution.
Description
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.
Product
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
Manufacturer(s)
Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →