Vyaire Medical is recalling 204 patient circuits for the 3100 High Frequency Oscillatory Ventilator because two specific models (29028-003 and 29028-004) that are only approved for use outside of the United States were mistakenly distributed within the U.S. These components are used to deliver life-sustaining ventilation to patients. While the recall involves 188 units of one model and 16 units of another, primarily distributed in Florida, consumers and healthcare providers should check their inventory for these specific model and lot numbers to ensure unapproved equipment is not in use.
The use of these patient circuits in the United States is unauthorized as they have not undergone the required regulatory review for the U.S. market, which could potentially lead to unforeseen device performance issues or safety risks during mechanical ventilation.
Contact manufacturer for instructions.
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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