Nebulizer (Direct Patient Interface)
FDA adverse event reports and recall history for nebulizer (direct patient interface) (product code CAF), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,821
- Deaths
- 43
- Injuries
- 255
- Malfunctions
- 2,380
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-09-14Open, ClassifiedProcess control
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
- 2019-02-04TerminatedProcess control
Portex 350 ml Sterile Water Humidifier w/5psi Adapt.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
- 2019-02-04TerminatedProcess control
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
- 2019-02-04TerminatedProcess control
Portex 1000 ml Sterile Water USP Pour Bottle
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
- 2019-02-04TerminatedProcess control
Portex 500 ml Sterile Water USP Pour Bottle
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
- 2019-02-04TerminatedProcess control
Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
- 2019-02-04TerminatedProcess control
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
- 2019-02-04TerminatedProcess control
Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
- 2019-02-04TerminatedProcess control
Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
- 2019-02-04TerminatedProcess control
Medline Prefilled 350 ml Sterile
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
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