Fresenius Medical Care is recalling 88 Novalung sensor boxes, which are critical components of the Novalung Console. This device is used to provide long-term heart and lung support for adults with acute respiratory or cardiopulmonary failure. The recall was initiated because the sensor box may trigger technical failure error messages (yellow #206 and red #208) during use, which can disrupt flow measurement and patient support. These units were distributed nationwide across the United States.
A technical failure in the sensor box can lead to inaccurate flow measurements or a sudden interruption in the extracorporeal circulation and gas exchange that the patient depends on for life support. This failure could result in serious patient harm or death if the system stops providing oxygenation and CO2 removal unexpectedly.
Technical support and manufacturer guidance
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.