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U.S. Department of Health and Human Services

Class 2 Device Recall Nasopore

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 Class 2 Device Recall Nasoporesee related information
Date Initiated by FirmFebruary 25, 2025
Date PostedMarch 28, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1479-2025
Recall Event ID 96393
510(K)NumberK070715 
Product Classification Polymer, ear, nose and throat, synthetic, absorbable - Product Code NHB
ProductNasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL
Code Information 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
Recalling Firm/
Manufacturer		 Stryker Corporation
1941 Stryker Way
Portage MI 49002-9711
For Additional Information ContactBrooke Thompson
269-290-0524
Manufacturer 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 2		Under Investigation by firm
ActionAn 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.
Quantity in Commerce182,344 total units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NHB
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