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QKRClass N

Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

FDA adverse event reports and recall history for face mask within the scope of the face mask and barrier face covering enforcement policy or face mask umbrella eua (product code QKR), from the public MAUDE/AEMS corpus and the live FDA recall database.

Total reports
225
Deaths
0
Injuries
200
Malfunctions
22

Reports per year

20
21
22
23
24

Source: FDA adverse event reports by year received, 20202024. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

  • Open, ClassifiedNo Marketing Application

    Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.

    Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.

Monitor face mask within the scope of the face mask and barrier face covering enforcement policy or face mask umbrella eua automatically

DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.