Recall Z-1476-2025
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 FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL
Codes / lots: 5400-020-108 UDI-DI: 07613327117226, Lot Numbers: 2023011317 2023021717 2023030932 2023040317 2023083017 2023102517 2024020517 2024080717; 5400-020-108ITL UDI-DI: 07613327117226, Lot Numbers: 2023012017 2023032817 2023042017 2023091117 2023111417 2023120517 2024011817 2023020732 2023041117 2023062017 2023092017 2023112017 2024010817 2024012417 2023031717 2023041417 2023082317 2023103117 2023112817 2024011217
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-1476-2025
- 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-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-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-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 |