Zyno Medical LLC recalls Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a pa…
- Recall date
- May 7, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1865-2025
- FDA classification
- Class I
- Brand / firm
- Zyno Medical LLC
- Sold / distributed
- US Nationwide
Why it was recalled
Unreleased software versions were installed on distributed devices without verification or validation.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
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