Recall Z-1471-2025
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 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
Codes / lots: 5400-010-008I UDI-DI: 07613154340804, Lot Numbers: 2022100514 2023011113 2023012412 2023041712 2023052212 2023062714 2023110214 2024011112 2022100616 2023011612 2023012712 2023050812 2023053012 2023062914 2023110714 2024012912 2022101733 2023011712 2023021014 2023050912 2023061516 2023070314 2023111312 2024013112 2022101815 2023011912 2023021414 2023051212 2023061614 2023091914 2023111512 2024020712 2022102412 2023012312 2023041212 2023051713 2023062614 2023092112 2023112212 2024021215 2024030612 2024031112 2024042412 2024042514 2024073114 2024080116 2024080913 2024082014; 5400-010-008ITL UDI-DI: 07613327359503, Lot Numbers: 2022092712 2022112912 2023020613 2023042612 2023090412 2023112814 2024021414 2024032612 2022092912 2022113012 2023020712 2023050512 2023090612 2023112914 2024021512 2024040215 2022093014 2022120112 2023020812 2023051012 2023090714 2023113014 2024021612 2024040414 2022100432 2022120212 2023020913 2023051512 2023091312 2023120114 2024021912 2024041614 2022101212 2022120532 2023022112 2023051616 2023091414 2024010914 2024022112 2024041712 2022102114 2022120533 2023030614 2023052312 2023092214 2024011012 2024022212 2024051312 2022102612 2022120632 2023030712…
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-1471-2025
- 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-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 |