Nasopore FD Nasal Dressing (Stryker) – Packaging Seal Issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
Brand
Stryker Corporation
Lot Codes / Batch Numbers
5400-020-108 UDI-DI: 07613327117226, 5400-020-108ITL UDI-DI: 07613327117226
Products Sold
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
Stryker Corporation is recalling Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL due to 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, . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
An Urgent Medical Device Recall notification letter dated 2/24/25 was sent to customers. Actions to be taken 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return the enclosed Business Reply Form (BRF), even if the affected product is no longer in inventory, to the email Instruments.Recalls@stryker.com. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A replacement will be provided upon receipt of the recalled product. 5. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. Instruments.recalls@stryker.com. RESPONSE IS REQUIRED.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026