Nasopore Nasal Dressings Recalled Due to Breached Sterility Seals
Stryker Corporation is recalling Nasopore nasal dressings due to potential breaches in packaging sterility seals that could compromise product sterilization. Approximately 182,344 units have been distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a breached sterility seal represents a risk-of-harm product where no injury has been reported yet. This satisfies the High severity criterion.
Plain-English summary
Stryker Corporation is recalling Nasopore 4cm Standard 2PK and Nasopore 4cm Firm 2PK nasal dressings due to a defect in the packaging seals. The affected products have Catalog Numbers 5400-212-004S (Standard) and 5400-222-004S (Firm). A total of 182,344 units have been distributed nationwide.
The packaging on some units may have bubbles in the blister seal area. These seals act as a sterile barrier to keep the product sterile until it is opened and used. When a bubble is present, it indicates the sterility seal has been compromised.
Consumers and healthcare facilities who have these products should verify their lot numbers. Affected lot numbers are 2024011914 for Standard dressings, and 2024021212 and 2024052813 for Firm dressings. Do not use any products with these lot numbers. Contact Stryker Corporation for instructions on returning or replacing affected units.
The recalled product
- Product
- Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
- Manufacturer
- Stryker Corporation
- Category
- Medical Device — Nasal Dressing
- Affected units
- 182,344
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 5400-212-004S UDI-DI: 07613154340842
- Lot Numbers: 2024011914
- 5400-222-004S UDI-DI: 07613327359473
- Lot Numbers: 2024021212 2024052813
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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