CLASS I Device recall · Reported 13 Feb 2019 · FDA Enforcement Report
Medline 300- Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿ recalled
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical is recalling Medline 300- Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿, distributed nationwide in the US. The recall was initiated on 5 Sep 2017 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0717-2019
- FDA event ID
- 81021
- Recalling firm
- Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical, Vernon Hills, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 5 Sep 2017
- FDA classified
- 4 Feb 2019
- Reported
- 13 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 5 Sep 2017 | Recall initiated by company | |
| 4 Feb 2019 | Classified by FDA | +517 days |
| 13 Feb 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿
Where it was distributed
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, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.
Nationwide ArizonaCaliforniaColoradoFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouriMississippiNorth Carolina
Questions about this recall
Why was it recalled?
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Which lots are affected?
Model # HCS00300 Lot Number: ¿Y576
Where was it sold?
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, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
12 other products · FDA event 81021This product is part of a recall event; the main page for the event is Portex Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿ recalled.
More recalls from Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Portex Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ recalled | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical | Sterility | Nationwide |
| Device | CLASS I | Portex Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ recalled | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical | Sterility | Nationwide |
| Device | CLASS I | Portex Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ recalled | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical | Sterility | Nationwide |
| Device | CLASS I | Portex Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ recalled | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical | Sterility | Nationwide |
| Device | CLASS I | Intermed Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ recalled | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |