Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208I...
FDA Device Recall #Z-1477-2025 — Class II — February 25, 2025
Recall Summary
| Recall Number | Z-1477-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 25, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Corporation |
| Location | Portage, MI |
| Product Type | Devices |
| Quantity | 182,344 total units |
Product Description
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
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.
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
5400-020-208 UDI-DI: 07613327117233, Lot Numbers: 2022093020 2023011632 2023041321 2023062320 2023092220 2023112232 2024032120 2024052420 2022093021 2023011932 2023042120 2023062220 2023092932 2023112420 2024032820 2024052320 2022100720 2023012732 2023042121 2023073120 2023101220 2023112320 2024032920 2024060620 2022100620 2023013033 2023050320 2023073121 2023101221 2023120120 2024040520 2024060720 2022101320 2023020132 2023050220 2023081520 2023101921 2023113020 2024040420 2024062020 2022101420 2023020632 2023051620 2023081521 2023101920 2023120632 2024041820 2024062120 2022101720 2023022033 2023051720 2023082520 2023102721 2023121533 2024041920 2024070420 2022102120 2023030220 2023052620 2023082521 2023102720 2024010532 2024042632 2024070520 2022102720 2023030320 2023052520 2023083120 2023110320 2024020120 2024042520 2024071538 2022102820 2023032420 2023060120 2023090120 2023110220 2024020220 2024042620 2024071738 2022110220 2023032320 2023060220 2023090820 2023110733 2024030820 2024050821 2022110320 2023032920 2023060820 2023090620 2023110920 2024030720 2024050820 2022112932 2023033020 2023060920 2023091520 2023110921 2024031420 2024051520 2023010433 2023040732 2023061520 2023091420 2023111720 2024031520 2024051721 2023010932 2023041320 2023061620 2023092120 2023111620 2024032220 2024052332 7; 5400-020-208ITL UDI-DI: 07613327602623, Lot Numbers: 2024052333
Other Recalls from Stryker Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2282-2026 | Class II | Neptune Smart Docking Station (120V), Catalog N... | May 6, 2026 |
| Z-2166-2026 | Class II | Thermedx FluidSmart Urology Tube Set REF LL0006... | Apr 9, 2026 |
| Z-1427-2026 | Class II | MOLLI 2 System System includes: MM1000 (Pack ... | Jan 21, 2026 |
| Z-0599-2026 | Class II | NICO Myriad Handpiece Product Number/Product... | Oct 31, 2025 |
| Z-0601-2026 | Class II | NICO BrainPath; Product Number/Product Name ... | Oct 31, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.