Nasopore Nasal Dressing Recall Due to Breached Sterile Packaging
Stryker Corporation is recalling Nasopore nasal dressings due to defects in blister seals that may compromise sterility. Affected products may have bubbles on the seal, indicating the sterile barrier has been breached.
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 FDA Class II recall involves sterile medical devices where the protective blister seal may be breached. No illnesses or injuries have been reported, placing this in the 'risk-of-harm product' category where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling Nasopore Ex Firm 4cm and Nasopore Forte plus 4cm fragmentable nasal dressings. A total of 182,344 units have been distributed nationwide in the United States.
The recalled products may have bubbles or imperfections on the blister seal. The blister seal is designed to act as a sterile barrier. When a bubble is present on the seal, it indicates that the sterility barrier has been breached.
Affected lot numbers for the 5400-030-004 model include 2024052333, 2023012514, 2023050514, 2023080912, and 2024020214. For the 5400-030-004ITL model, affected lot numbers include 2023071933, 2023102714, and 2024012314.
The recalled product
- Product
- Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL
- 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 (4)
- 5400-030-004 UDI-DI: 07613154340835
- Lot Numbers: 2024052333 2023012514 2023050514 2023080912 2024020214
- 5400-030-004ITL UDI-DI: 07613327359442
- Lot Numbers: 2023071933 2023102714 2024012314
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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