The Recall Desk
SevereFDA (Devices)·Z-1867-2025·Announced 2025-06-18

Z-800W Infusion System Recalled for Unvalidated Software Installation

Zyno Medical LLC is recalling the Z-800W Infusion System because unreleased software versions were installed on devices without verification or validation.

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: This is a Class I recall of a medical device used for critical infusion therapy. The unvalidated software on a device intended to deliver blood and parenteral fluids poses a significant risk of harm, meeting the Severe criteria for FDA Class I recalls even without reported injuries.

Plain-English summary

The Z-800W Infusion System, which is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to patients, is being recalled by Zyno Medical LLC.

The recall affects 613 units of the Z-800W model (UDI-DI: 00814371020020) that were distributed nationwide. The reason for the recall is that unreleased software versions were installed on distributed devices without verification or validation.

If you are a healthcare facility or patient using this infusion system, contact Zyno Medical LLC or the FDA for instructions on the appropriate next steps and any remediation options available.

The recalled product

Product
Z-800W 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 Number: Z800W
  • UDI-DI
  • 00814371020020
  • Serial No. 700063
  • 700163
  • 700203
  • 700402
  • 700488
  • 700093
  • 700169
  • 700210
  • 700428
  • 700495
  • 700104
  • 700172
  • 700214
  • 700431
  • 700503
  • 700111
  • 700188

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 →

Related recalls

Same manufacturer · Zyno Medical LLC

See all →

Same hazard · software validation

See all →