The Recall Desk
SevereFDA (Devices)·Z-1865-2025·Announced 2025-06-18

Z-800 Infusion System recalled for unverified software installation

Zyno Medical LLC is recalling 613 units of the Z-800 Infusion System distributed nationwide because unreleased software versions were installed on the 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: The FDA classified this as a Class I recall for a critical medical device (infusion system) used for parenteral fluid and blood product delivery. Class I recalls indicate a serious hazard where use of the product will cause or may cause serious adverse health consequences or death, meeting the Severe criterion.

Plain-English summary

Zyno Medical LLC is recalling 613 units of the Z-800 Infusion System, a medical device intended to provide intravenous infusion of parenteral fluids, blood, and blood products to patients. The recall applies to devices distributed nationwide.

The devices were distributed with unreleased software versions that were installed without verification or validation. This failure to verify and validate the software before distribution poses a potential risk to patients who receive treatment using these devices.

Affected devices are identified by Model Z800, UDI-DI: 00814377102006, and specific serial numbers listed in the recall notice. Patients and healthcare providers who have received or are using Z-800 Infusion Systems should contact Zyno Medical LLC or the FDA for instructions on how to proceed with their affected devices.

The recalled product

Product
Z-800 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)

  • Lot Code: Model Number
  • Z800
  • UDI-DI: 00814377102006
  • Serial No.: 800242
  • 801925
  • 802867
  • 900875
  • 901058
  • 901089
  • 901101
  • 901126
  • 901143
  • 901567
  • 904021
  • 904073
  • 800378
  • 801950
  • 803020
  • 900914
  • 901061

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

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