Z-1474-2025Class II

Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number...

Name: Z-1474-2025 Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number...
Creator: Stryker Corporation
Published: 2025-02-25
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2025-02-25 / Open, Classified / root cause: packaging

FDA source

Stryker Corporation began a recall of Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL on 2025-02-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1474-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-25
Posted: 2025-03-28
Recalling firm: Stryker Corp.
Product: Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
Product code: NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
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.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: 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 [email protected]. 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. [email protected]. RESPONSE IS REQUIRED.
Distribution: US Nationwide distribution.
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1474-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1469-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-28
Z-1470-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-28
Z-1471-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-28
Z-1472-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-28
Z-1473-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-28
Z-1474-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-28
Z-1475-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-28
Z-1476-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-28
Z-1477-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-28
Z-1478-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-28
Z-1479-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-28
Z-1480-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-28
Z-1481-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-28
Z-1482-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-28

Product code NHB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)