Recall Z-1470-2025
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 Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
Codes / lots: 5400-010-004 UDI-DI: 07613154340798, Lot Numbers: 2022101814 2023021412 2023082413 2024022915 2022111414 2023051712 2023090114 2022102413 2023022133 2023090613 2024031915 2023011013 2023052415 2023110315 2022111413 2023050913 2023091912 2024032215 2023011913 2023061615 2023112314 2023011613 2023051213 2023103115 2024040214 2023020113 2023062132 2024011912 2023012413 2023071713 2023110812 2024052915 2023020333 2023062615 2024020813 2023012713 2023080812 2023112018 2024062412 2023020612 2023062915 2024080117 2023020912 2023081112 2024011613 2024080912 2023050414 2023070433 2024082216; 5400-010-004ITL UDI-DI: 07613327359435, Lot Numbers: 2022111414 2023051712 2023090114 2023011013 2023052415 2023110315 2023011913 2023061615 2023112314 2023020113 2023062132 2024011912 2023020333 2023062615 2024020813 2023020612 2023062915 2024080117 2023050414 2023070433 2024082216
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-1470-2025
- Initiated
- February 25, 2025
- Posted by FDA
- March 28, 2025
- Product code
- NHB – Polymer, Ear, Nose And Throat, Synthetic, Absorbable
- Quantity
- 182,344 total units
- 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-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-1474-2025 Class II | Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 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 |