Recall Z-1477-2025— Stryker Corporation

Name: FDA recall Z-1477-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-25

Class II · Ongoing

Class II FDA medical device recall by Stryker Corporation, initiated 2025-02-25. It names one FDA 510(k) clearance: K070715. Product: Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS). Reason: 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..

Recalling firm: Stryker Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-02-25
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K070715 — NASOPORE EARPolyganics B.V.,·cleared 2007-05-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.