FDA Device recall Z-1479-2025
Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL 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-1479-2025 |
| 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
Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL
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 | 5400-030-008 UDI-DI: 07613154340842, Lot Numbers: 2023012515 2023012715 2023022012 2023050814 2023072632 2023102312 202…5400-030-008 UDI-DI: 07613154340842, Lot Numbers: 2023012515 2023012715 2023022012 2023050814 2023072632 2023102312 2023102612 2024032514 2024040212; 5400-030-008ITL UDI-DI: 07613327359473, Lot Numbers: 2022092714 2023020633 2023032433 2023050915 2023052514 2023062216 2023082814 2023101112 2024031812 2022092914 2023020814 2023032814 2023051114 2023053115 2023062032 2023090618 2023101714 2024042212 2022101332 2023020915 2023033016 2023051215 2023060914 2023082215 2023100312 2023102014 2024042312 2022121932 2023021416 2023050115 2023052214 2023061412 2023082312 2023100412 2024030414 2024061814 2022122032 2023022032 2023050515 2023052412 2023061514 2023082514 2023100912 2024030512 2024062814 |
|---|
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-1479-2025%22
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