Zyno Medical LLC: Medical Device Recall in 2025 - (Recall #: Z-1867-2025)

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-800W 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-1867-2025

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 Number: Z800W; UDI-DI; 00814371020020; Serial No. 700063; 700163; 700203; 700402; 700488; 700093; 700169; 700210; 700428; 700495; 700104; 700172; 700214; 700431; 700503; 700111; 700188; 700225; 700440; 700510; 700120; 700189; 700230; 700449; 700513; 700135; 700190; 700285; 700460; 700541; 700145; 700192; 700375; 700471; 700481; 700150; 700195; 700391; 700472; 700397; 700159; 700199; 700393; 700478; 700201; 700162.

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated