FDA Medical devices recall ·
Nasopore 4cm Standard 2PK fragmentable nasal dressing recall
- Recall number
- Z-1480-2025
- 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 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
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
5400-212-004S UDI-DI: 07613327500387, Lot Numbers: 2024011914; 5400-222-004S UDI-DI: 07613327500479, Lot Numbers: 2024021212 2024052813
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-1480-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.