Recall archive / FDA device enforcement
Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL — FDA record Z-1474-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 25, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Stryker Corporation
- Quantity
- Not supplied
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1474-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 9, 2025
- Recall initiation date
- Feb 25, 2025
- Center classification date
- Mar 28, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.