FDA Device recall Z-1482-2025
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S by Stryker, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1482-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-25 |
| Published | 2025-04-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Stryker |
| Distribution | US |
Product
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
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.
Identifiers
| code_info | 5400-222-208S UDI-DI: 07613327500486, Lot Numbers: 2024020221 2024051720 2024082321 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1482-2025%22
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