Drug recall
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
FDA recall event 96393 · Class II · Stryker Corporation
Key facts
| Event ID | 96393 |
|---|---|
| Recall numbers | Z-1469-2025, Z-1470-2025, Z-1471-2025, Z-1472-2025, Z-1473-2025, Z-1474-2025, Z-1475-2025, Z-1476-2025, Z-1477-2025, Z-1478-2025, Z-1479-2025, Z-1480-2025 and 2 more |
| Recalling firm | Stryker Corporation |
| Product type | Devices |
| Products | Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S, Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS), Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL, Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S, Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL and 8 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Feb 25, 2025 |
| Report date | Apr 9, 2025 |
| City | Portage |
| State | MI |
| Country | United States |
| FEI number | 3015967359 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: