Medical device recalls Moderate risk

Stryker Corporation recalls Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL

Recall date
February 25, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1470-2025
FDA classification
Class II
Brand / firm
Stryker Corporation
Sold / distributed
US Nationwide distribution.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL

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