CLASS II ONGOING Device recall · Reported 9 Apr 2025 · FDA Enforcement Report
Hemopore nasal/sinus temporary wound dressing recalled by Stryker
Stryker is recalling Hemopore nasal/sinus temporary wound dressing, distributed nationwide in the US. The recall was initiated on 25 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1482-2025
- FDA event ID
- 96393
- Recalling firm
- Stryker, Portage, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Feb 2025
- FDA classified
- 28 Mar 2025
- Reported
- 9 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 25 Feb 2025 | Recall initiated by company | |
| 28 Mar 2025 | Classified by FDA | +31 days |
| 9 Apr 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Which lots are affected?
5400-222-208S UDI-DI: 07613327500486, Lot Numbers: 2024020221 2024051720 2024082321
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
13 other products · FDA event 96393This product is part of a recall event; the main page for the event is Otopore Cylinder outer ear wound dressing, Firm recalled by Stryker.
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