Approximately 853,657 Smiths Medical Portex tracheostomy tubes, including the BLUselect, BLUgriggs, and BLUperc models, are being recalled worldwide due to a manufacturing defect. This defect can cause the pilot balloon to disconnect from the tracheostomy inflation line. The recall covers products manufactured in the United States and distributed across clinical and home healthcare settings.
If the pilot balloon disconnects, the tube's cuff may deflate, leading to a loss of the airway seal. This can cause inadequate ventilation, loss of lung volume, or the aspiration of fluids into the lungs, potentially resulting in serious injury or death for patients who depend on these devices to breathe.
Healthcare provider notification and potential product exchange
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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