Recall Z-1474-2025
Stryker Corporation · initiated February 25, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
Codes / lots: 5400-020-004 UDI-DI: 07613154340811, Lot Numbers: 2022100314 2023013132 2023042514 2023081512 2023110114 2024011514 2024032512 2024082612 2022102514 2023021012 2023050216 2023082811 2023110614 2024011814 2024042914 2023011332 2023021512 2023060214 2023090514 2023111616 2024021213 2024052812 2023012632 2023030814 2023062214 2023091813 2023112112 2024030412 2024073012 ; 5400-020-004ITL UDI-DI: 07613327359459, Lot Numbers: 2022102012 2023011714 2023011714 2023051614 2023081812 2023110914 2024012614 2024030716 2022111514 2023012014 2023012014 2023052314 2023083116 2023112414 2024020714 2024031214 2023010914 2023020214 2023020214 2023062733 2023100914 2023112912 2024021514 2024031814 2023011214 2023051112 2023051112 2023080112 2023101214 2024010912 2024022014 2024032816 2024042314 2024051314 2024052212 2024060512 2024061114
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.
FDA-determined cause: Under Investigation by firm
Action taken
An Urgent Medical Device Recall notification letter dated 2/24/25 was sent to customers. Actions to be taken 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return the enclosed Business Reply Form (BRF), even if the affected product is no longer in inventory, to the email Instruments.Recalls@stryker.com. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A replacement will be provided upon receipt of the recalled product. 5. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. Instruments.recalls@stryker.com. RESPONSE IS REQUIRED.
Details
- Recall number
- Z-1474-2025
- Initiated
- February 25, 2025
- Posted by FDA
- March 28, 2025
- Product code
- NHB – Polymer, Ear, Nose And Throat, Synthetic, Absorbable
- Distribution
- US Nationwide distribution.
- Recalling firm
- Stryker Corporation, Portage, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1469-2025 Class II | Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1470-2025 Class II | Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1471-2025 Class II | Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1472-2025 Class II | Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1473-2025 Class II | Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1475-2025 Class II | Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1476-2025 Class II | Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1477-2025 Class II | Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1478-2025 Class II | Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1479-2025 Class II | Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1480-2025 Class II | Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1481-2025 Class II | Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and…There is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |
| Z-1482-2025 Class II | Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208SThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging.… | 02/25/2025Open, Classified |