Smiths Medical ASD Inc. has recalled approximately 464,032 units of various Portex brand respiratory devices, including nasopharyngeal airways, swivel connectors, Y-pieces, speaking valves, and Thermovent heat/moisture exchangers. The recall was issued due to a defect in the sterile packaging seals that may compromise the sterility of the products. If these devices are used while unsterile, they could lead to serious respiratory infections or other complications for patients. No incidents or injuries have been reported to date.
A defect in the sterile packaging seal can allow contaminants or bacteria to enter the package, potentially leading to healthcare-acquired infections in patients requiring respiratory support. Because these devices are used directly in or near the airway, compromised sterility poses a direct risk to the patient's respiratory system.
Quantity affected: 251,591 units. Individual sizes listed by reference number.
Quantity affected: 34,141 units.
Quantity affected: 9,133 units.
Quantity affected: 27,971 units.
Quantity affected: 141,196 units.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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