Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Z-800F Infusion System. Intended to provide intravenous infusion of parenteral Recalled by Zyno Medical LLC Due to Unreleased software versions were installed on distributed devices...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zyno Medical LLC directly.
Affected Products
Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Quantity: 613 units
Why Was This Recalled?
Unreleased software versions were installed on distributed devices without verification or validation.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zyno Medical LLC
Zyno Medical LLC has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report