FDAFDA · Food and drugs·Recall number Z-1482-2025
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
Published April 9, 2025 · Recall initiated: February 25, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Corporation
- Distributor
- US Nationwide distribution.
- Lot
- 5400-222-208S UDI-DI: 07613327500486, Lot Numbers: 2024020221 2024051720 2024082321
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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