Decontamination Systems For N95 Respirators
FDA adverse event reports and recall history for decontamination systems for n95 respirators (product code QKY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 305
- Deaths
- 0
- Injuries
- 72
- Malfunctions
- 233
Reports per year
Source: FDA adverse event reports by year received, 2020–2021. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- TerminatedUnder Investigation by firm
Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of Filtering Facepiece Respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
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