Z-800WFRecalls & reported problems

Zyno Medical LLC · Large volume infusion pump · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Zyno Medical Z-800WF is a large volume infusion pump. Of its 316 reports, 315 are malfunctions and 1 is an injury, mostly describing flow and alarm problems and failed maintenance tests. There are 4 recalls, all open, covering unreleased software, an air-in-line software error, power supply modules that may not charge the battery, and alarm volume that may drop. Reports fell to 0 in the last 12 months from 6 in the previous 12.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 316
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 4

Summary

The FDA's MAUDE database contains 316 adverse event reports that list this exact device (DI 00814371020037), received between Dec 20, 2016 and Jul 29, 2025 — classified as 1 injury, 315 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (148 reports).

4 FDA recall records name this device's identifier, 4 still open.

5 other recalls cover devices cleared under the same FDA submission (K130690); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

May 7, 2025Open, Classified
Unreleased software versions were installed on distributed devices without verification or validation.
Z-1868-2025 · Root cause: Software design (manufacturing process) · FDA record ↗
Sep 13, 2024Open, Classified
There is a defect in the air-in-line software algorithm.
Z-0005-2025 · Root cause: Process change control · FDA record ↗
Jun 4, 2024Open, Classified
Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to the battery having insufficient or no charge available to the pump when it is unplugged from the AC mains power.
Z-2263-2024 · Root cause: Process control · FDA record ↗
Dec 20, 2023Open, Classified
When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death
Z-1183-2024 · Root cause: Software design · FDA record ↗

Most reported problems

Device problems

Infusion or Flow Problem148
Device Alarm System94
Excess Flow or Over-Infusion71
Calibration Problem64
Device Operates Differently Than Expected59
Pressure Problem59
Low Audible Alarm30
Improper Flow or Infusion20

Patient problems

No Clinical Signs, Symptoms or Conditions239
No Known Impact Or Consequence To Patient45
No Consequences Or Impact To Patient12
No Information12
Not Applicable9
No Patient Involvement5
Air Embolism2
Blood Loss1

Recent adverse event reports

The 25 most recent of 316 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 29, 2025Pressure Problem; Pressure Problem
INTUVIE RECEIVED A REPORT INDICATING THAT AN INFUSION PUMP FAILED THE 30PSI OCCLUSION TEST, RECORDING A PRESSURE OF 17.00PSI WHICH IS OUTSIDE THE ACCEPTABLE RANGE OF 22 TO 38 PSI. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22646999 ↗
MalfunctionNov 11, 2024Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem; Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem
ON 10/04/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE DEVICE WAS REPORTED TO HAVE A FLOW RATE OFFSET ISSUE. NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20657863 ↗
MalfunctionNov 8, 2024Excess Flow or Over-Infusion; Failure to Power Up; Calibration Problem; Infusion or Flow Problem; Power Problem; Complete Loss of Power; Excess Flow or Over-Infusion; Failure to Power Up; Calibration Problem; Infusion or Flow Problem; Power Problem; Complete Loss of Power
ON 10/23/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE DEVICE POWER ON FAILED AND THERE WAS A FLOW RATE DEVIATION AT 11.83%. NO REPORT OF PATIENT INJURED/HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20637558 ↗
MalfunctionNov 7, 2024Device Alarm System; Excess Flow or Over-Infusion; Calibration Problem; Device Sensing Problem; Infusion or Flow Problem; Pressure Problem; Device Alarm System; Excess Flow or Over-Infusion; Calibration Problem; Device Sensing Problem; Infusion or Flow Problem; Pressure Problem
ON 10/22/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THEY RECEIVED A PRESSURE TEST FAILURE AND A FLOWRATE RATE ISSUE DURING TESTING. NO PATIENT INVOLVED REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20636447 ↗
MalfunctionNov 1, 2024Device Alarm System; Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem; Pressure Problem; Device Alarm System; Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem; Pressure Problem
ON 10/17/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE DEVICE HAD FAILED THE 30 PSI AND THE FLOWRATE TEST. 30 PSI TEST FAILED AT 43, WITH A MAXIMUM ALLOWABLE VALUE OF 38 AND THE FLOW RATE WAS ADJUST IT CLOSE TO A 5% DEVIATION, NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20584997 ↗
MalfunctionNov 1, 2024Device Alarm System; Pressure Problem; Device Alarm System; Pressure Problem
ON 10/11/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), FAILED THE 30 PSI OCCLUSION TEST AT 61. NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20584961 ↗
MalfunctionOct 31, 2024Device Alarm System; Calibration Problem; Infusion or Flow Problem; Air/Gas in Device; Device Alarm System; Calibration Problem; Infusion or Flow Problem; Air/Gas in Device
ON 10/17/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE AIR IN LINE ALERT POPPED UP MULTIPLE TIMES DURING THE PRESSURE TEST. NO PATIENT INJURED/HARMED REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20584940 ↗
MalfunctionOct 31, 2024Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem; Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem
ON 10/15/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE DEVICE WAS REPORTED TO HAVE A FLOW RATE OFFSET ISSUE. FAILED FLOWRATE TEST WITH A DEVIATION OF (B)(4). NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20584922 ↗
MalfunctionOct 30, 2024Infusion or Flow Problem; Infusion or Flow Problem
ON (B)(6) 2024, ZNYO MEDICAL RECEIVED A REPORT FROM THE CUSTOMER REPORTING THAT THE PUMP WAS INFUSING AT A RATE SLOWER THAT WAS SET. NO PATIENT INVOLVED REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20575291 ↗
MalfunctionOct 30, 2024Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem; Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem
ON 10/17/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE DEVICE WAS REPORTED TO HAVE A FLOW RATE OFFSET ISSUE. FLOW RATE DEVIATION TOO HIGH (6.88). NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20574575 ↗
MalfunctionOct 29, 2024Device Alarm System; Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem; Pressure Problem; Device Alarm System; Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem; Pressure Problem
ON 10/15/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE DEVICE HAD FAILED THE 30 PSI AND THE FLOOWRATE TEST. OCCLUSION AT TOO HIGH OF A PSI VALUE (40.16) FLOW RATE DEVIATION TOO HIGH (4.76). NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20563977 ↗
MalfunctionOct 28, 2024Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem; Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem
ON 10/15/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE DEVICE WAS REPORTED TO HAVE A FLOW RATE OFFSET ISSUE. FLOW RATE DEVIATION WAS TOO HIGH (5.8) . NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20552073 ↗
MalfunctionOct 27, 2024Device Alarm System; Pressure Problem; Device Alarm System; Pressure Problem
ON 10/10/2024, ZNYO MEDICAL RECEIVED A REPORT FROM A CUSTOMER REPORTING THEY WERE GETTING OCCLUSION ALARMS ON THE PUMP. NO PATIENT HARM/INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20541678 ↗
MalfunctionOct 27, 2024Device Alarm System; Pressure Problem; Device Alarm System; Pressure Problem
ON 10/10/2024, ZYNO MEDICAL RECEIVED A REPORT FROM A CUSTOMER REPORTING THEY WERE GETTING OCCLUSION ALARMS ON THE PUMP. NO PATIENT HARM/INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20541670 ↗
MalfunctionOct 26, 2024Device Alarm System; Pressure Problem; Device Alarm System; Pressure Problem
ON (B)(4).2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), FAILED THE 30 PSI OCCLUSION TEST AT 21. NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20540605 ↗
MalfunctionOct 26, 2024Device Alarm System; Excess Flow or Over-Infusion; Mechanical Problem; Calibration Problem; Infusion or Flow Problem; Pressure Problem; Device Alarm System; Excess Flow or Over-Infusion; Mechanical Problem; Calibration Problem; Infusion or Flow Problem; Pressure Problem
ON 10/09/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE PUMP HAD A SYSTEM ERROR INTERRUPTION MID TEST AND A FLOW RATE OFFSET ISSUE. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20540552 ↗
MalfunctionOct 25, 2024Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem; Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem
ON 10/08/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE DEVICE WAS REPORTED TO HAVE A FLOW RATE OFFSET ISSUE. NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20539749 ↗
MalfunctionOct 25, 2024Device Alarm System; Pressure Problem; Device Alarm System; Pressure Problem
ON 10/09/2024, ZNYO MEDICAL RECEIVED A REPORT FROM A CUSTOMER REPORTING THAT THE PUMP CONTINUES TO ALARM OCCLUSION. NO PATIENT INJURED/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20539519 ↗
MalfunctionOct 24, 2024Device Alarm System; Pressure Problem; Device Alarm System; Pressure Problem
ON 10/08/2024, ZNYO MEDICAL RECEIVED A REPORT FROM A CUSTOMER REPORTING THAT THE PUMP WAS ALARMING OCCLUSION. NO PATIENT INJURED/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20529093 ↗
MalfunctionOct 24, 2024Device Alarm System; Pressure Problem; Device Alarm System; Pressure Problem
ON 10/08/2024, ZNYO MEDICAL RECEIVED A REPORT FROM A CUSTOMER REPORTING THAT THE PUMP WAS ALARMING OCCLUSION. NO PATIENT INJURED/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20527566 ↗
MalfunctionOct 24, 2024Infusion or Flow Problem; Infusion or Flow Problem
ON10/08/2024, ZNYO MEDICAL RECEIVED A REPORT FROM THE CUSTOMER REPORTING THAT THE PUMP NOT INFUSING AS PROGRAMMED. NO PATIENT INVOLVED REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20524736 ↗
MalfunctionOct 22, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
ON 10/04/2024, ZNYO MEDICAL RECEIVED A REPORT FROM THE CUSTOMER REPORTING A ZYNO PUMP HAD SYSTEM ERROR. NO PATIENT INJURY/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20510784 ↗
MalfunctionOct 22, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
ON 10/04/2024, ZNYO MEDICAL RECEIVED A REPORT FROM THE CUSTOMER REPORTING A ZYNO PUMP HAD SYSTEM ERROR. NO PATIENT INJURY/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20510698 ↗
MalfunctionOct 22, 2024Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem; Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem
ON 09/30/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE DEVICE WAS REPORTED TO HAVE A FLOW RATE OFFSET ISSUE. NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20508079 ↗
MalfunctionOct 22, 2024Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
ON 10/03/2024, ZNYO MEDICAL RECEIVED A REPORT FROM THE CUSTOMER REPORTING THAT WHEN THEY HAD AN INFUSION THE PUMP NEEDED SERVICE AS IT IS GIVING THEM A SYSTEM ERROR WHEN THEY WERE TRYING TO USE IT. NO PATIENT INJURY/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20502336 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130690. One submission often covers many models, so check the product and lot details in each record.

Z-1867-2025 · May 7, 2025 · Open, Classified
Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Z-1866-2025 · May 7, 2025 · Open, Classified
Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Z-1865-2025 · May 7, 2025 · Open, Classified
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Z-0506-2025 · Oct 18, 2024 · Open, Classified
Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, an
Z-0523-2025 · Sep 30, 2024 · Open, Classified
Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, b

Device details

UDI-DI	`00814371020037`
Brand	Z-800WF
Model	Z-800WF
Company	Zyno Medical LLC
Product code	FRN · Pump, Infusion
Class	Class 2
FDA submission	K130690
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jul 4, 2022

Device type (GMDN): Bedside infusion pump, single-channel

An electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.

Other Pump, Infusion devices

Alaris 8100
Carefusion 303, Inc. · Pump, infusion
2 recalls2 deaths650,218 reports
Alaris 8100
Carefusion 303, Inc. · Pump, infusion
4 recalls78 deaths344,514 reports
Alaris 8015
Carefusion 303, Inc. · Pump, infusion
2 recalls45 deaths148,093 reports
BD® Alaris™ Pump Module, Model 8100
Carefusion 303, Inc. · Pump, infusion
5 recalls30 deaths51,256 reports
Alaris 8110
Carefusion 303, Inc. · Pump, infusion
2 recalls4 deaths21,956 reports
Alaris 8110
Carefusion 303, Inc. · Pump, infusion
2 recalls2 deaths15,547 reports
Alaris 8015
Carefusion 303, Inc. · Pump, infusion
3 recalls6 deaths13,022 reports
CADD 21-6500-51
Icu Medical, Inc. · Pump, infusion
2 deaths8,231 reports

All Pump, Infusion devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page