Zyno Medical LLC has recalled approximately 613 Z-800 series Infusion Systems, including models Z-800, Z-800F, Z-800W, and Z-800WF. These devices, which provide intravenous infusion of blood and fluids to patients, were distributed with unreleased software versions that were never verified or validated for use. There have been no reports of incidents or injuries associated with this issue to date.
Using a medical infusion device with unverified software can lead to incorrect fluid delivery, dosing errors, or total device failure. These issues can result in serious health consequences for patients receiving life-critical treatments or medications.
Recall #: Z-1865-2025
Recall #: Z-1866-2025
Recall #: Z-1867-2025
Recall #: Z-1868-2025
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.