Medex
FDA adverse event reports naming Medex as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MEDEX.
- Total reports
- 2,061
- Deaths
- 5
- Injuries
- 106
- Malfunctions
- 1,932
Reports per year
Source: FDA adverse event reports by year received, 1996–2011. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Pump, InfusionFRN863
- Set, Administration, IntravascularFPA474
- Transducer, Blood-Pressure, ExtravascularDRS301
- Stopcock, I.V. SetFMG184
- Tubing, Pressure And AccessoriesBYX43
- Syringe, PistonFMF37
- Arterial Blood Sampling KitCBT31
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ23
- Infusor, Pressure, For I.V. BagsKZD23
- Catheter, Intravascular, DiagnosticDQO20
Recent recalls
- 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.
- 2019-02-04TerminatedProcess control
Portex Unit Dose 5 ml Normal Saline (0.9%)
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
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