Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿ Recalled by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Due to Lack of sterility assurance: leaking containers which could...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company directly.
Affected Products
Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿
Quantity: 128,000 sold to Japan only
Why Was This Recalled?
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report