Nasopore Nasal Dressing Recall Due to Compromised Sterile Packaging Seals
Stryker Corporation is recalling Nasopore nasal dressings due to potentially compromised sterile packaging seals. Affected units totaling 182,344 may have lost sterility, posing a contamination risk.
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 is an FDA Class II medical device recall for a breach of the sterile barrier on nasal surgical dressings. While no illnesses or injuries have been reported, the potential for product contamination and infection exists due to the compromised sterility seal, placing this at the High severity level per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling Nasopore 4cm Standard 2PK (Catalog Number 5400-212-004S) and Nasopore 4cm Firm 2PK (Catalog Number 5400-222-004S) nasal dressings. The recall affects a total of 182,344 units distributed nationwide. These fragmentable nasal dressings are used in nasal surgery and post-operative nasal care.
The recall was initiated because blister seals on the product packaging may develop bubbles in the seal area. When a bubble appears, it indicates that the sterile barrier has been breached. A compromised sterile seal means the product may no longer be sterile and could potentially be contaminated during storage or use.
No illnesses or injuries have been reported in connection with this issue. The affected lot numbers are: 2024011914 (for Catalog Number 5400-212-004S) and 2024021212 and 2024052813 (for Catalog Number 5400-222-004S). Healthcare facilities and users should discontinue use of affected lots and contact Stryker Corporation for replacement units or further instructions.
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
- 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: 07613327500387
- Lot Numbers: 2024011914
- 5400-222-004S UDI-DI: 07613327500479
- 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.
See all 14 products in this recall →Related recalls
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