FDA Device recall Z-1474-2025
Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL 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-1474-2025 |
| 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 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
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 | 5400-020-004 UDI-DI: 07613154340811, Lot Numbers: 2022100314 2023013132 2023042514 2023081512 2023110114 2024011514 202…5400-020-004 UDI-DI: 07613154340811, Lot Numbers: 2022100314 2023013132 2023042514 2023081512 2023110114 2024011514 2024032512 2024082612 2022102514 2023021012 2023050216 2023082811 2023110614 2024011814 2024042914 2023011332 2023021512 2023060214 2023090514 2023111616 2024021213 2024052812 2023012632 2023030814 2023062214 2023091813 2023112112 2024030412 2024073012 ; 5400-020-004ITL UDI-DI: 07613327359459, Lot Numbers: 2022102012 2023011714 2023011714 2023051614 2023081812 2023110914 2024012614 2024030716 2022111514 2023012014 2023012014 2023052314 2023083116 2023112414 2024020714 2024031214 2023010914 2023020214 2023020214 2023062733 2023100914 2023112912 2024021514 2024031814 2023011214 2023051112 2023051112 2023080112 2023101214 2024010912 2024022014 2024032816 2024042314 2024051314 2024052212 2024060512 2024061114 |
|---|
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-1474-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.