Zyno Medical LLC: Medical Device Recall in 2024 - (Recall #: Z-1183-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF

Product Classification:

Class II

Date Initiated: December 20, 2023

Date Posted: March 6, 2024

Recall Number: Z-1183-2024

Event ID: 93857

Reason for Recall:

When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death

Status: Ongoing

Product Quantity: 574 units

Code Information:

UDI: 00814371020037 software version 5.2.05

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated