Smiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking
Smiths Medical is recalling Portex 350 ml Sterile Water Humidifiers because leaking containers may expose patients to infectious agents.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source explicitly identifies this as an FDA Class I recall, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, is recalling Portex 350 ml Sterile Water Humidifiers with 5psi adapters. The recall involves 70,860 units of Model # 352 with lot numbers A214, A215, Z263, Z532, and Z555.
The recall is due to a lack of sterility assurance. The containers may leak, which could lead to exposure to infectious agents. This is classified as an FDA Class I recall.
The affected products were distributed nationwide in the United States, including Puerto Rico, and in several international countries including Austria, Canada, the Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland. Users should stop using the affected units and contact the manufacturer for instructions.
The recalled product
- Product
- Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
- Category
- Medical Device — Humidifier
- Affected units
- 70,860
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model # 352 Lot Numbers: A214
- A215
- Z263
- Z532
- and Z555
Distribution
Part of a larger recall action
This product is one of 13 recalled by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
Same manufacturer · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
See all →- CriticalMedline Prefilled 550 ml Sterile Bags Recalled for Leaking
FDA (Devices) · 2019-02-13
- CriticalSmiths Medical Recalls Portex Sterile Water Pour Bottles Due to Leaking
FDA (Devices) · 2019-02-13
- HighSmiths Medical Recalls Intermed 550 ml Sterile Water Humidifiers
FDA (Devices) · 2019-02-13
- CriticalSmiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking
FDA (Devices) · 2019-02-13
- HighSmiths Medical Recalls Portex Normal Saline Units Due to Sterility Concerns
FDA (Devices) · 2019-02-13
Same hazard · infection
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19