The Recall Desk
SevereFDA (Devices)·Z-1866-2025·Announced 2025-06-18

Z-800F Infusion System Recall Due to Unvalidated Software Versions

Zyno Medical LLC is recalling the Z-800F Infusion System because unreleased software versions were installed on distributed devices without verification or validation. This poses a risk to patients receiving intravenous infusion therapy.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I for a medical device involved in critical patient care (intravenous infusion). Unvalidated software on a life-sustaining infusion system poses a direct risk of serious patient harm, meeting the Class I + medical device criteria for Severe classification.

Plain-English summary

Zyno Medical LLC is recalling the Z-800F Infusion System, which is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to patients. The reason for the recall is that unreleased software versions were installed on distributed devices without verification or validation.

Approximately 613 units of the Z-800F Infusion System have been distributed nationwide. The affected devices are Model No. Z800F with the UDI-DI: 00814371020013 and specific serial numbers listed in the FDA recall notice.

Healthcare facilities and providers who have received this device should immediately cease use and contact Zyno Medical LLC for further instructions regarding the device and any necessary corrective actions.

The recalled product

Product
Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Manufacturer
Zyno Medical LLC
Category
Medical Device — Infusion System
Hazard
Affected units
613

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model No: Z800F
  • UDI-DI: 00814371020013
  • Serial No. 600091
  • 600133
  • 600203
  • 600259
  • 600320
  • 600361
  • 600404
  • 600446
  • 600482
  • 600526
  • 600565
  • 600601
  • 600094
  • 600138
  • 600204
  • 600261
  • 600321
  • 600362

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Zyno Medical LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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Same hazard · software validation

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