Nasopore nasal dressing recall: compromised sterile barrier seals
Stryker recalls Nasopore 4cm fragmentable nasal dressings due to potential blister seal damage that compromises the sterile barrier. Nationwide distribution affected.
What this means for you
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 recall concerning a structural defect that compromises the sterile barrier of a medical device. No illnesses, injuries, or hospitalizations have been reported. Per the rubric, risk-of-harm products without reported injury fall in the High category.
Plain-English summary
Stryker Corporation has recalled Nasopore 4cm fragmentable nasal dressings in both Firm (Catalog Number 5400-020-004) and Forte (Catalog Number 5400-020-004ITL) versions. The recall was issued because blister seals on the product packaging can develop a bubble on the seal area, which indicates a breach in the sterile barrier.
The affected products were distributed nationwide across the United States. Numerous lot numbers from the manufacturing period spanning 2022 through mid-2024 are included in this recall.
Healthcare facilities and individuals with affected product should discontinue use immediately. Stryker should be contacted for instructions on returning the product or obtaining replacements. While no illnesses or injuries have been reported associated with this issue, a compromised sterile barrier on a medical dressing poses a potential risk of contamination or infection.
The recalled product
- Product
- Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
- Manufacturer
- Stryker Corporation
- Category
- Medical Device — Nasal Dressing
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)
- 5400-020-004 UDI-DI: 07613154340811
- 5400-020-004ITL UDI-DI: 07613327359459
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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