Stryker nasal wound dressing recalled for defective sterile packaging seal
Stryker Corporation is recalling 182,344 units of Hemopore 2PK nasal/sinus wound dressing due to potential bubbles in blister seals that indicate sterility breach. Affected lot numbers are 2024020221, 2024051720, and 2024082321.
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: FDA Class II medical device with a potential sterility barrier breach on a nasal/sinus wound dressing. No illnesses or injuries have been reported; the hazard is theoretical contamination risk rather than confirmed harm.
Plain-English summary
Stryker Corporation is recalling Hemopore 2PK nasal/sinus temporary wound dressing (Catalog Number 5400-222-208S), affecting 182,344 units distributed nationwide.
The product has a potential manufacturing defect in which the blister seal packaging may develop a bubble in the seal area. This seal functions as the sterile barrier protecting the device. A bubble in this seal indicates that the sterility seal has been breached, potentially compromising the sterility of the wound dressing.
The affected units can be identified by lot numbers 2024020221, 2024051720, and 2024082321. The device is intended as a temporary nasal/sinus wound dressing for managing and controlling bleeding in nasal or sinus wounds.
The recalled product
- Product
- Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
- Manufacturer
- Stryker Corporation
- Category
- Medical Device — Wound 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)
- 5400-222-208S UDI-DI: 07613327500486
- Lot Numbers: 2024020221 2024051720 2024082321
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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