Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
Summary
The FDA issued a Class II for Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-0 by Stryker Corporation. 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, .
Details
Source
Device Recall
External ID
Z-1476-2025
Action Date
2025-04-09
Status
Ongoing
Category
device
Product Description
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
Lot/Code Info: 5400-020-108 UDI-DI: 07613327117226, Lot Numbers: 2023011317 2023021717 2023030932 2023040317 2023083017 2023102517 2024020517 2024080717; 5400-020-108ITL UDI-DI: 07613327117226, Lot Numbers: 2023012017 2023032817 2023042017 2023091117 2023111417 2023120517 2024011817 2023020732 2023041117 2023062017 2023092017 2023112017 2024010817 2024012417 2023031717 2023041417 2023082317 2023103117 2023112817 2024011217
Quantity Affected: 182,344 total units
Reason for Recall
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-25
Company
Portage, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 182 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Corporation have FDA actions?
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1476-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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