Data Foundry

Medical device recalls 2025

Nasopore 4cm Standard 2PK fragmentable nasal dressing — Class II medical device recall Z-1481-2025

Ongoing recall by Stryker Corporation, reported 2025-04-09, distributed nationwide. There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. T

Recall numberZ-1481-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmStryker Corporation, Portage, MI, United States
Recall initiated2025-02-25
Classified2025-03-28
Reported by FDA2025-04-09
DistributedNationwide (US)
Quantity182,344 units
Reason classessterility, packaging
UPC / GTIN / UDI-DI07613154340842, 07613327359473
Lot numbers2024011914, 2024021212, 2024052813, 5400-222-004S
Model numbers5400-212-004S, 5400-222-004S

Product

Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1481-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.