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Nasopore recallZ-1479-2025 · Stryker Corporation · initiated Feb 25, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1479-2025
Status
Open, Classified
Initiated by the company
Feb 25, 2025
Posted by the FDA
Mar 28, 2025
Recalling firm
Stryker Corporation
Quantity
182,344 total units
Product code
NHB
FDA submissions
K070715
Distribution
US Nationwide distribution.

Product description

Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL

Code information (models, lots, serial numbers)

5400-030-008 UDI-DI: 07613154340842, Lot Numbers: 2023012515 2023012715 2023022012 2023050814 2023072632 2023102312 2023102612 2024032514 2024040212; 5400-030-008ITL UDI-DI: 07613327359473, Lot Numbers: 2022092714 2023020633 2023032433 2023050915 2023052514 2023062216 2023082814 2023101112 2024031812 2022092914 2023020814 2023032814 2023051114 2023053115 2023062032 2023090618 2023101714 2024042212 2022101332 2023020915 2023033016 2023051215 2023060914 2023082215 2023100312 2023102014 2024042312 2022121932 2023021416 2023050115 2023052214 2023061412 2023082312 2023100412 2024030414 2024061814 2022122032 2023022032 2023050515 2023052412 2023061514 2023082514 2023100912 2024030512 2024062814

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 96393).

Sources and updates

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