Nasopore Standard Nasal Dressing Recalled Due to Sterility Seal Defects
Stryker is recalling 182,344 units of Nasopore Standard nasal dressings nationwide due to potential bubbles in blister seals that may breach the sterility barrier and increase 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 recall involves a potential compromised sterility barrier on a medical device used in nasal procedures, presenting a risk of contamination. Per the rubric, risk-of-harm products where injury has not been reported score at the High level.
Plain-English summary
Stryker Corporation is recalling 182,344 units of Nasopore Standard 8cm fragmentable nasal dressing (Catalog Numbers 5400-010-008 and 5400-010-008ITL) distributed nationwide in the United States. The product is a sterile nasal dressing used in nasal and sinus surgical procedures.
The recall is being issued because blister seals on the product packaging may develop bubbles on the seal area. The sterile barrier is critical to patient safety—a bubble in the seal indicates that the sterility seal has been breached, which could compromise the product's sterile condition and increase risk of contamination.
Healthcare facilities and providers using this product should be aware of this potential defect. Affected units can be identified by the lot numbers listed in the recall notice. Contact Stryker Corporation or the FDA for information on affected product replacement or return.
The recalled product
- Product
- Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
- 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)
- 5400-010-008I UDI-DI: 07613154340804
- 5400-010-008ITL UDI-DI: 07613327359503
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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