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# Zyno Medical Recalls Z-800 Infusion Devices
- URL: https://www.fdaweb.com/zyno-medical-recalls-z-800-infusion-devices/
- Published: 2024-10-10T12:00:00.000Z
- Updated: 2026-09-14T14:43:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157954

Zyno Medical is recalling (Class 1 device correction) various models of its Z-800 Infusion System because there is a defect in the air in-line software algorithm. FDA determined the cause to be related to the firm’s “process change control,” according to a [recall notice](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=210103&ref=fdaweb.com).

An “Urgent: Medical Device Correction” was sent to customers advising them that the company was mitigating the issue by removing the “faulty software and correctly installing software that is free of this defect,” according to the notice.