The Recall Desk

FDA (Devices) recall action 96796

Zyno Medical LLC recalled 4 products on 2025-06-18

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2025-06-18
Critical
0
Units
2,452

Why these products were recalled

Unreleased software versions were installed on distributed devices without verification or validation.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • SevereFDA (Devices)··2025-06-18

    Z-800F Infusion System Recall Due to Unvalidated Software Versions

    Zyno Medical LLC is recalling the Z-800F Infusion System because unreleased software versions were installed on distributed devices without verification or validation. This poses a risk to patients receiving intravenous infusion therapy.

    Product
    Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2025-06-18

    Z-800W Infusion System Recalled for Unvalidated Software Installation

    Zyno Medical LLC is recalling the Z-800W Infusion System because unreleased software versions were installed on devices without verification or validation.

    Product
    Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2025-06-18

    Z-800 Infusion System recalled for unverified software installation

    Zyno Medical LLC is recalling 613 units of the Z-800 Infusion System distributed nationwide because unreleased software versions were installed on the devices without verification or validation.

    Product
    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2025-06-18

    Z-800WF Infusion System software verification defect recall

    Zyno Medical LLC is recalling 613 units of the Z-800WF Infusion System because unreleased software versions were installed on distributed devices without verification or validation.

    Product
    Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Distribution
    0 states