FDA Devices recall · Reported February 13, 2019
Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company recalled Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ - a critical-severity action.
Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ was recalled by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company in February 13, 2019. Reason: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.. Check the official notice for the remedy. Verify recall #Z-0710-2019 with the FDA Devices before acting.
The recall
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company issued this critical-severity FDA Devices recall-Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents..
- Critical
- severity level
- 71K units
- affected scope
- Class I
- classification
- February 13, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0710-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
Reason for recall
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0710-2019 |
| Date reported | February 13, 2019 |
| Date initiated | September 5, 2017 |
| Recalling firm | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company |
| Firm location | Vernon Hills, IL |
| Affected scope | 70,860 |
| Distribution | Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0710-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026