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# Zyno Medical Recalls Infusion Pumps
- URL: https://www.fdaweb.com/zyno-medical-recalls-infusion-pumps/
- Published: 2025-06-16T12:00:00.000Z
- Updated: 2026-09-14T15:14:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159363

Zyno Medical has recalled certain Z-800, Z-800F, Z-800W and Z-800WF infusion pumps because they were released to customers with incorrect software versions that had not undergone required verification and validation testing. “As a result, these pumps can experience unexpected performance problems, including issues with essential functions and risk measures such as air in line detection, alarm volume, and reverse flow prevention,” a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/infusion-pump-recall-zyno-medical-removes-certain-z-800-series-infusion-pumps-due-software-issue?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. The worst-case scenarios of incorrect air in line detection and incorrect audio alarms associated with other failures could result in serious harms such as under- or over-delivery of drugs, and air in line that infuses a venous air embolism of up to 1mL, it says.

The pumps are used to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified health care professional. To date, Zyno Medical has not reported any serious injuries or deaths, according to the recall notice.