Z-800FRecalls & reported problems

Zyno Medical LLC · Large volume infusion pump · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Quick summary

This Zyno Z-800F large volume infusion pump delivers fluids to patients. Its 703 reports, with 4 injuries and no deaths, often describe flow problems, over-infusion and calibration problems. There are 3 open recalls, covering unverified software, an air-in-line software problem, and power supplies that may not charge the battery. Reports in the last 12 months number 3, down from 8 in the year before.

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: 703
Deaths reported: 0
Injuries reported: 4
Recalls naming it: 3

Summary

The FDA's MAUDE database contains 703 adverse event reports that list this exact device (DI 00814371020013), received between Dec 20, 2016 and Jun 8, 2026 — classified as 4 injuries, 698 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (460 reports).

3 FDA recall records name this device's identifier, 3 still open.

6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-1866-2025 · Root cause: Software design (manufacturing process) · Recall details · 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 · Recall details · 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 · Recall details · FDA record ↗

Most reported problems

Device problems

Infusion or Flow Problem460
Excess Flow or Over-Infusion232
Calibration Problem207
Device Alarm System157
Pressure Problem94
Device Operates Differently Than Expected57
Air/Gas in Device43
Insufficient Flow or Under Infusion26

Patient problems

No Clinical Signs, Symptoms or Conditions613
Not Applicable27
No Known Impact Or Consequence To Patient24
No Patient Involvement14
No Consequences Or Impact To Patient12
Chest Pain5
Nausea3
Dyspnea2

Recent adverse event reports

The 25 most recent of 703 reports, in the reporter's own words as published by the FDA.

InjuryJun 8, 2026Air/Gas in Device
INTUVIE RECEIVED A VOLUNTARY MEDWATCH FORM FDA 3500 (MW5187474) REPORT STATING: ¿THEIR INFUSION PUMP ALARM DIDN'T GO OFF. WOKE UP WITH CHEST PAINS AFTER FALLING ASLEEP WHILE BEING INFUSED AND WENT TO THE EMERGENCY ROOM. PUMP WAS GIVEN TO THE REPORTER ON 2026. Z800 ZYNO INFUSION PUMP RECALLED 06-16-2025 DUE TO AIR IN LINE SOFTWARE DEFECT. THE PHARMACY GAVE REPORTER A NEW BRAND OF DEVICE WITH MISSING PARTS AND TOLD REPORTER TO CONTINUE USING OLD PUMP UNTIL THE NEW PIECES WERE PROVIDED.¿
Patient problems: Chest Pain
MAUDE report 25434080 ↗
InjuryJun 8, 2026Air/Gas in Device
INTUVIE RECEIVED A VOLUNTARY MEDWATCH FORM FDA 3500 (MW5187476) REPORT STATING: ¿THEIR INFUSION PUMP ALARM DIDN'T GO OFF. WOKE UP WITH CHEST PAINS AFTER FALLING ASLEEP WHILE BEING INFUSED AND WENT TO THE EMERGENCY ROOM. PUMP WAS GIVEN TO THE REPORTER ON 2026. Z800 ZYNO INFUSION PUMP RECALLED 06-16-2025 DUE TO AIR IN LINE SOFTWARE DEFECT. THE PHARMACY GAVE REPORTER A NEW BRAND OF DEVICE WITH MISSING PARTS AND TOLD REPORTER TO CONTINUE USING OLD PUMP UNTIL THE NEW PIECES WERE PROVIDED.¿
Patient problems: Chest Pain
MAUDE report 25433056 ↗
InjuryJun 8, 2026Air/Gas in Device
INTUVIE RECEIVED A VOLUNTARY MEDWATCH FORM FDA 3500 (MW5187475) REPORT STATING: "THEIR INFUSION PUMP ALARM DIDN¿T GO OFF. WOKE UP WITH CHEST PAINS AFTER FALLING ASLEEP WHILE BEING INFUSED AND WENT TO THE EMERGENCY ROOM. PUMP WAS GIVEN TO THE REPORTER ON 2026. Z800 ZYNO INFUSION PUMP RECALLED ON (B)(6) 2025 DUE TO AIR IN LINE SOFTWARE DEFECT. THE PHARMACY GAVE REPORTER A NEW BRAND OF DEVICE WITH MISSING PARTS AND TOLD REPORTER TO CONTINUE USING OLD PUMP UNTIL THE NEW PIECES WERE PROVIDED."
Patient problems: Chest Pain
MAUDE report 25432603 ↗
MalfunctionSep 5, 2025Pressure Problem; Pressure Problem
INTUVIE RECEIVED A REPORT INDICATING THAT AN INFUSION PUMP FAILED THE 30 PSI OCCLUSION TEST, RECORDING A PRESSURE OF 18.2 PSI 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 22984831 ↗
MalfunctionSep 5, 2025Protective Measures Problem; Protective Measures Problem
DURING ROUTINE SERVICE AT RIGHT WAY MEDICAL, THE DEVICE WAS OBSERVED TO HAVE NO AUDIBLE ALARMS. THE SPEAKER WAS NONFUNCTIONAL, RESULTING IN THE ABSENCE OF SOUND WHEN KEYS WERE PRESSED, AS WELL AS NO AUDIBLE INDICATION WHEN THE INFUSION WAS COMPLETE. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22984744 ↗
MalfunctionAug 18, 2025Pressure Problem; Pressure Problem
INTUVIE RECEIVED A REPORT INDICATING THAT AN INFUSION PUMP FAILED THE 30PSI OCCLUSION TEST, RECORDING A PRESSURE OF 16PSI 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 22827767 ↗
MalfunctionAug 11, 2025Pressure Problem; Pressure Problem
INTUVIE RECEIVED A REPORT INDICATING THAT AN INFUSION PUMP FAILED THE 30PSI OCCLUSION TEST, RECORDING A PRESSURE OF 19PSI 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 22769651 ↗
MalfunctionJun 16, 2025Pressure Problem; Pressure Problem
INTUVIE RECEIVED A REPORT INDICATING THAT AN INFUSION PUMP FAILED THE 30PSI OCCLUSION TEST, RECORDING A PRESSURE OF 12PSI, 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 22214324 ↗
MalfunctionNov 3, 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 (8.34). NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20594847 ↗
MalfunctionNov 2, 2024Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem; Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem
ON 10/10/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE DEVICE WAS REPORTED TO HAVE A FLOW RATE OFFSET ISSUE. FLOW RATE TESTING FAILED DUE TO A (B)(4) DEVIATION, WHICH DOES NOT MEET THE STANDARD RATE OF +/- 4.5%. NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20594821 ↗
MalfunctionNov 1, 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 (11.61.). NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20585895 ↗
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 (B)(6) 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 FAILED AT THE DEVIATION OF 4.97%. NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20574255 ↗
MalfunctionOct 28, 2024Device Alarm System; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Calibration Problem; Infusion or Flow Problem; Air/Gas in Device; Device Alarm System; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Calibration Problem; Infusion or Flow Problem; Air/Gas in Device
ON 10/15/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE PUMP HAD CONSTANT AIR-IN-LINE ALARMS AND THE FLOW RATE TESTING FAILED DUE TO A 10.32% DEVIATION, WHICH DOES NOT MEET THE STANDARD RATE OF +/- 4.5%. NO PATIENT INJURY/HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20551026 ↗
MalfunctionOct 28, 2024Infusion or Flow Problem; Infusion or Flow Problem
ON (B)(6) 2024, ZNYO MEDICAL RECEIVED A REPORT FROM THE CUSTOMER REPORTING THAT THE PUMP INFUSING SLOWER THAN PROGRAMMED. THE TEST RESULTS WERE AT 6% THE PUMP DELIVERED 10.84ML. AT -6% THE PUMP DELIVERED 10.01ML. NO PATIENT INVOLVED REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20550491 ↗
MalfunctionOct 28, 2024Infusion or Flow Problem; Infusion or Flow Problem
ON 10/15/2024, ZYNO MEDICAL RECEIVED A REQUEST FROM THE CUSTOMER STATING THEY NEEDED THE HEX FILE. PER THE CUSTOMER THE PUMP CALIBRATED THE VOLUME.NO PATIENT WAS INVOLVED AS IT WAS DISCOVERED DURING TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20549490 ↗
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. PUMP FAILED WITH A DEVIATION OF 6.43%. NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20549471 ↗
MalfunctionOct 28, 2024Infusion or Flow Problem; Infusion or Flow Problem
ON 10/15/2024, ZYNO MEDICAL RECEIVED A REQUEST FROM THE CUSTOMER STATING THEY NEEDED THE HEX FILE. PER THE CUSTOMER THE PUMP CALIBRATED THE VOLUME. NO PATIENT WAS INVOLVED AS IT WAS DISCOVERED DURING TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20547785 ↗
MalfunctionOct 28, 2024Device Alarm System; Device Sensing Problem; Pressure Problem; Device Alarm System; Device Sensing Problem; Pressure Problem
ON 10/11/2024, ZNYO MEDICAL RECEIVED A REPORT FROM THE CUSTOMER STATING THE DEVICE WAS DISPLAYING A PRESSURE ERROR EVEN AFTER TRYING MULTIPLE NEW PRESSURE SENSORS HAPPENED DURING TESTING. NO REPORT PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20546984 ↗
MalfunctionOct 27, 2024Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem; Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem
ON 10/10/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE DEVICE WAS REPORTED TO HAVE A FLOW RATE OFFSET ISSUE. UNABLE TO UPLOAD HEXFILE .NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20541702 ↗
MalfunctionOct 27, 2024Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem; Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem
ON 10/10/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE DEVICE WAS REPORTED TO HAVE A FLOW RATE OFFSET ISSUE. FLOW RATE TESTING FAILED DUE TO A -4.61% DEVIATION, WHICH DOES NOT MEET THE STANDARD RATE OF +/- 4.5%. NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20541697 ↗
MalfunctionOct 26, 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 10/092024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE FLOW RATE TEST FAILED AT (B)(4). NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20540593 ↗
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 FROM THE CUSTOMER THAT THEY HAD UPDATED THE FLOWRATE FROM 4% TO -7%. TEST RESULTS WERE AT 4% THE PUMP DELIVERED 11.28ML. AT 7% THE PUMP DELIVERED 9.98ML. DISCOVERED DURING ROUTINE PM TESTING. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20539293 ↗
MalfunctionOct 24, 2024Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem; Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem
ON 10/07/2024, 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 (5.00). NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20526437 ↗
MalfunctionOct 24, 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. FLOW RATE DEVIATION TOO HIGH (7.32). NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20524936 ↗
MalfunctionOct 24, 2024Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem; Excess Flow or Over-Infusion; Calibration Problem; Infusion or Flow Problem
ON 10/07/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE DEVICE WAS REPORTED TO HAVE A FLOW RATE OFFSET ISSUE. FLOW RATE TESTING FAILED DUE TO A 6.62% DEVIATION, WHICH DOES NOT MEET THE STANDARD RATE OF +/- 4.5%. NO REPORT PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20524640 ↗

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-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-1868-2025 · May 7, 2025 · Open, Classified
Z-800WF 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
Z-1183-2024 · Dec 20, 2023 · Open, Classified
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervisi

Device details

UDI-DI	`00814371020013`
Brand	Z-800F
Model	Z-800F
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.

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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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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