Zyno Medical LLC: Medical Device Recall in 2025 - (Recall #: Z-1868-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: May 7, 2025

Date Posted: June 18, 2025

Recall Number: Z-1868-2025

Event ID: 96796

Reason for Recall:

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

Status: Ongoing

Product Quantity: 613 units

Code Information:

Model No. Z800WF; UDI-DI: 00814371020037; Serial No. 500004; 500005; 500006; 500810; 500812; 500813; 501748; 503680; 503681; 503682.

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated