FDA Device recall Z-1473-2025
Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL 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-1473-2025 |
| 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 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
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 | 5400-020-008 UDI-DI: 07613154340828, Lot Numbers:2022101214 2023011115 2023021612 2023061932 2023101632 2024011532 2024…5400-020-008 UDI-DI: 07613154340828, Lot Numbers:2022101214 2023011115 2023021612 2023061932 2023101632 2024011532 2024051512 2022101314 2023011212 2023031312 2023062612 2023110232 2024021914 2024072631 2022101414 2023011314 2023031414 2023062812 2023113034 2024022731 2024081312 2022101914 2023011615 2023042413 2023072433 2023120732 2024030431 2024082614 2023010912 2023011814 2023050212 2023091112 2023121532 2024031932 2024082812 2022101214 2023011115 2023021612 2023061932 2023101632 2024011532 2024051512 2023011015 2023021313 2023051014 2023091212 2023121832 2024050814 ; 5400-020-008ITL UDI-DI: 07613327359428, Lot Numbers: 2022101912 2023030914 2023070715 2023073132 2023090512 2023101012 2023110832 2023120612 2022102614 2023031015 2023070712 2023080132 2023090712 2023101014 2023111314 2023120633 2022110714 2023032932 2023071132 2023080232 2023090814 2023101133 2023110932 2023120714 2022110814 2023042614 2023071133 2023080233 2023091214 2023101114 2023111332 2023120712 2022110914 20230 |
|---|
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-1473-2025%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.