FDA Medical devices recall ·
Nasopore Standard 4cm fragmentable nasal dressing recall
- Recall number
- Z-1470-2025
- 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 Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
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
5400-010-004 UDI-DI: 07613154340798, Lot Numbers: 2022101814 2023021412 2023082413 2024022915 2022111414 2023051712 2023090114 2022102413 2023022133 2023090613 2024031915 2023011013 2023052415 2023110315 2022111413 2023050913 2023091912 2024032215 2023011913 2023061615 2023112314 2023011613 2023051213 2023103115 2024040214 2023020113 2023062132 2024011912 2023012413 2023071713 2023110812 2024052915 2023020333 2023062615 2024020813 2023012713 2023080812 2023112018 2024062412 2023020612 2023062915 2024080117 2023020912 2023081112 2024011613 2024080912 2023050414 2023070433 2024082216; 5400-010-004ITL UDI-DI: 07613327359435, Lot Numbers: 2022111414 2023051712 2023090114 2023011013 2023052415 2023110315 2023011913 2023061615 2023112314 2023020113 2023062132 2024011912 2023020333 2023062615 2024020813 2023020612 2023062915 2024080117 2023050414 2023070433 2024082216
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-1470-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.