Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical recalls

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical has 18 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 13 Feb 2019. The most frequent reason is sterility.

Total recalls18since 2018
Last 12 months0reported
Class I1372% of total
Ongoing0latest 13 Feb 2019

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 13 72%Class II 5 28%Class III 0 0%

Why medex cardio-pulmonary inc., d.b.a. smiths medical is recalled

Product types

By year

All medex cardio-pulmonary inc., d.b.a. smiths medical recalls, newest first

18 total
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IPortex Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ recalledMedex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalSterilityNationwide
DeviceCLASS IPortex Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ recalledMedex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalSterilityNationwide
DeviceCLASS IPortex Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ recalledMedex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalSterilityNationwide
DeviceCLASS IPortex Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ recalledMedex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalSterilityNationwide
DeviceCLASS IIntermed Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ recalledMedex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalSterilityNationwide
DeviceCLASS IMedline Prefilled Sterile¿¿ ¿ recalled by Medex Cardio-Pulmonary Inc.Medex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalSterilityNationwide
DeviceCLASS IPortex Unit Dose Normal Saline ¿ recalledMedex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalSterilityNationwide
DeviceCLASS IPortex Unit Dose Normal Saline (0.9%)¿¿¿¿ ¿ recalledMedex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalSterilityNationwide
DeviceCLASS IMedline 300- Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿ recalledMedex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalSterilityNationwide
DeviceCLASS IIntermed Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ recalledMedex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalSterilityNationwide
DeviceCLASS IMedline Prefilled Sterile¿¿¿¿ ¿¿¿¿ ¿ recalledMedex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalSterilityNationwide
DeviceCLASS IPortex Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ recalledMedex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalSterilityNationwide
DeviceCLASS IPortex Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿ recalledMedex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalSterilityNationwide
DeviceCLASS IIIrrisept OR, Finished Bottle Assembly STEP recalledMedex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalSterility37 states
DrugCLASS IISterile Eyewash (sterile isotonic phosphate buffered saline recalledMedex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalLead & Heavy MetalsIA, WI
DrugCLASS IISterile Eyewash (sterile isotonic phosphate buffered saline recalledMedex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalLead & Heavy MetalsIA, WI
DrugCLASS IISterile Eyewash (sterile isotonic phosphate buffered saline recalledMedex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalLead & Heavy MetalsIA, WI
DrugCLASS IISterile Eyewash (sterile isotonic phosphate buffered saline recalledMedex Cardio-Pulmonary Inc., d.b.a. Smiths MedicalLead & Heavy MetalsIA, WI

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.