Nasopore nasal dressing may have compromised sterile packaging
Stryker is recalling Nasopore Standard 4cm nasal dressings because the blister seals may develop bubbles, potentially compromising the sterility barrier. Affected units should not be used.
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: This recall involves a potential sterility breach on a medical device used internally (nasal dressing). Although no illnesses or injuries have been reported, the risk of contamination and subsequent infection represents a significant harm scenario where injury has not yet been reported, meeting the criteria for High (Score 3) severity.
Plain-English summary
Stryker Corporation is recalling Nasopore Standard 4cm fragmentable nasal dressings (Catalog Numbers 5400-010-004 and 5400-010-004ITL) distributed nationwide in the United States. The recall affects 182,344 units.
The recalled dressings may have defective blister seals that develop bubbles during manufacturing or handling. When a bubble appears on the seal area, it indicates that the sterility barrier has been breached. This means the product may no longer be sterile.
A sterile nasal dressing is essential for safe use inside the nose. Non-sterile products used internally pose a risk of infection or other complications.
Consumers and healthcare providers should check their inventory against the provided lot numbers and contact Stryker or their supplier to arrange return or replacement of affected products.
The recalled product
- Product
- Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
- 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 (2)
- 5400-010-004 UDI-DI: 07613154340798
- 5400-010-004ITL UDI-DI: 07613327359435
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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