FDA Medical devices recall ·
Nasopore Ex Firm 4cm fragmentable nasal dressing recall
- Recall number
- Z-1478-2025
- Date
- (initiated February 25, 2025)
- Company / brand
- Stryker Corporation
1941 Stryker Way, Portage, MI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 182,344 total units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
5400-030-004 UDI-DI: 07613154340835, Lot Numbers: 2024052333 2023012514 2023050514 2023080912 2024020214; 5400-030-004ITL UDI-DI: 07613327359442, Lot Numbers: 2023071933 2023102714 2024012314
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1478-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.