Z-800WRecalls & reported problems

Zyno Medical LLC · Large volume infusion pump · Class 2

Data updated Oct 13, 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

The Zyno Medical Z-800W is a large volume infusion pump used to deliver fluids and medications. The 31 reports mostly describe the pump behaving differently than expected, with flow problems such as over-infusing, running too slowly, or alarms going off, plus one dead speaker. No deaths or injuries are reported. Three open recalls cite a power supply module that fails to charge the battery, a defect in the air-in-line software, and unverified software installed on distributed pumps.

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: 31
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 3

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00814371020020), received between Jan 6, 2017 and May 5, 2021 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (21 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

May 7, 2025Open, Classified
Unreleased software versions were installed on distributed devices without verification or validation.
Z-1867-2025 · 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 ↗

Most reported problems

Device problems

Device Operates Differently Than Expected21
Infusion or Flow Problem11
Device Alarm System6
Excess Flow or Over-Infusion4
Improper Flow or Infusion3
Insufficient Flow or Under Infusion2
Connection Problem1
Insufficient Device Problem Information1

Patient problems

No Known Impact Or Consequence To Patient23
Not Applicable4
No Clinical Signs, Symptoms or Conditions2
No Consequences Or Impact To Patient1
No Patient Involvement1

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 5, 2021Device Alarm System; Device Alarm System
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11776835 ↗
MalfunctionOct 8, 2020Improper Flow or Infusion; Infusion or Flow Problem; Improper Flow or Infusion; Infusion or Flow Problem
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2020-00017).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10652603 ↗
MalfunctionSep 14, 2019Device Alarm System; No Audible Alarm; Device Alarm System; No Audible Alarm
ON 07/19/2019, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A SPEAKER MALFUNCTION ISSUE. A USER FACILITY REPRESENTATIVE EMAILED THE DISTRIBUTOR ON 07/01/2019, STATING THAT A PUMP HAD A SPEAKER THAT "WENT OUT, NO SOUND." NO PATIENT WAS INVOLVED. THE MEDICATION ASSOCIATED WITH THE INCIDENT WAS GAZVYA. DEVICE OPERATOR WAS A RN.
Patient problems: No Patient Involvement
MAUDE report 9056940 ↗
MalfunctionNov 27, 2017Insufficient Flow or Under Infusion; Device Operates Differently Than Expected; Improper Flow or Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Device Operates Differently Than Expected; Improper Flow or Infusion; Infusion or Flow Problem
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00313).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7061635 ↗
MalfunctionNov 8, 2017Device Operates Differently Than Expected; Infusion or Flow Problem; Device Operates Differently Than Expected; Infusion or Flow Problem
THE USER REPORTED A FLOW RATE ISSUE OF THE INFUSION PUMP ON (B)(6) 2017 TO ZYNO MEDICAL. "NOT ACCURATE ON TIME TO INFUSE TAKING TOO LONG. CALIBRATION IS SUSPECTED TO BE OFF. IT WAS REMOVED FROM PATIENT CARE AREA, ONCE IT WAS IDENTIFIED. NO PATIENT HARM OCCURRED. IDENTIFIED 10/23, PARAMETERS UNKNOWN, AS THE PUMP WAS LEFT FOR ME BY ANOTHER INFUSION ROOM NURSE."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7009424 ↗
MalfunctionSep 5, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00264).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6841930 ↗
MalfunctionJul 27, 2017Excess Flow or Over-Infusion; Device Operates Differently Than Expected; Infusion or Flow Problem; Excess Flow or Over-Infusion; Device Operates Differently Than Expected; Infusion or Flow Problem
THE USER REPORTED THAT PUMP WAS OVER-INFUSING. "PUMP DID NOT INFUSE CORRECTLY. APPROXIMATELY 30 MINUTES BEFORE THE BAG WAS EMPTY. YES PT WAS INVOLVED, THE INFUSION WAS RUNNING INTO HIS VEIN, NO INJURY." NO PATIENT INJURY OR HARM OCCURRED IN THIS CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6747606 ↗
MalfunctionJun 28, 2017Insufficient Flow or Under Infusion; Device Operates Differently Than Expected; Insufficient Flow or Under Infusion; Device Operates Differently Than Expected
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00236).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6675041 ↗
MalfunctionJun 28, 2017Device Operates Differently Than Expected; Infusion or Flow Problem; Device Operates Differently Than Expected; Infusion or Flow Problem
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00234).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6675035 ↗
MalfunctionJun 28, 2017Device Operates Differently Than Expected; Infusion or Flow Problem; Device Operates Differently Than Expected; Infusion or Flow Problem
THE USER REPORTED THAT THE PUMP HAD CALIBRATION ISSUE. "ISSUES WERE IDENTIFIED AT THE TIME OF PROGRAMMING, SO NO PATIENTS WERE INJURED AS THEY WERE PULLED OUT OF CIRCULATION".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6675034 ↗
MalfunctionJun 28, 2017Device Operates Differently Than Expected; Infusion or Flow Problem; Device Operates Differently Than Expected; Infusion or Flow Problem
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00233).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6675026 ↗
MalfunctionJun 28, 2017Device Operates Differently Than Expected; Infusion or Flow Problem; Device Operates Differently Than Expected; Infusion or Flow Problem
THE USER REPORTED THAT THE PUMP HAD A DOOR ISSUE OR A CALIBRATION ISSUE. "700272 HAS BEEN SITTING ON MY DESK FOR A WHILE, SO I AM UNSURE WHO PUT IT THERE OR WHY. ONE OF OUR NURSES DID JUST MENTION THAT SHE THINKS IT WAS BECAUSE WHEN AN IV BAG WAS HUNG, AND THE DOOR CLOSED, IT CONTINUED TO FLOW FREELY. AGAIN, I'M NOT CERTAIN OF THIS. PATIENTS WERE INVOLVED, BUT DURING PROGRAMMING THE ISSUES WERE NOTICED." NO PATIENT INJURY OR HARM OCCURED FOR THIS CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6675007 ↗
MalfunctionMay 24, 2017Excess Flow or Over-Infusion; Device Operates Differently Than Expected; Excess Flow or Over-Infusion; Device Operates Differently Than Expected
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00126).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6587622 ↗
MalfunctionMay 24, 2017Excess Flow or Over-Infusion; Device Operates Differently Than Expected; Excess Flow or Over-Infusion; Device Operates Differently Than Expected
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00125).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6587620 ↗
MalfunctionMay 24, 2017Excess Flow or Over-Infusion; Device Operates Differently Than Expected; Excess Flow or Over-Infusion; Device Operates Differently Than Expected
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00124).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6587617 ↗
MalfunctionMay 11, 2017Sparking; Device Operates Differently Than Expected; Sparking; Device Operates Differently Than Expected
THE USER REPORTED THAT THE ALARM DID NOT SOUND WHEN INFUSION WAS COMPLETED AUTOMATICALLY. THE GREEN LED LIGHT WAS OFF UPON INFUSION COMPLETION. THE PUMP WAS PLUGGED IN. THERE WAS ALSO A SMALL SPARK WHEN THE PUMP WAS SHUT OFF. NO PATIENT INJURY OR HARM OCCURRED IN THIS CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6559987 ↗
MalfunctionMay 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00099).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6537099 ↗
MalfunctionMay 2, 2017Device Operates Differently Than Expected; Infusion or Flow Problem; Device Operates Differently Than Expected; Infusion or Flow Problem
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00098).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6537096 ↗
MalfunctionMay 2, 2017Device Operates Differently Than Expected; Infusion or Flow Problem; Device Operates Differently Than Expected; Infusion or Flow Problem
THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00096).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6537085 ↗
MalfunctionMar 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE USER REPORTED THAT A PUMP POWERED ITSELF OFF DURING ACTIVE PATIENT USE. NO PATIENT INJURY OR HARM OCCURRED FOR THIS CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6379098 ↗
MalfunctionFeb 15, 2017Device Operates Differently Than Expected; Improper Flow or Infusion; Device Operates Differently Than Expected; Improper Flow or Infusion
THE USER REPORTED THAT THE PUMP "WAS SUPPOSED TO INFUSE FOR 2 HOURS, BUT ACTUALLY INFUSED OVER 1 1/2 HOURS". NO PATIENT INJURY OR HARM HAS OCCURRED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6331304 ↗
MalfunctionFeb 15, 2017Connection Problem; Wireless Communication Problem; Connection Problem; Wireless Communication Problem
A ZYNO PRODUCT MANAGER REPORTED THAT TWO PUMPS WOULD NOT CONNECT TO THE WIRELESS SYSTEM FOR PATIENT QUERY AND NEED TO BE REPLACED. THIS FUNCTION WAS USED PRIOR TO AN INFUSION, SO NO INFUSION HAD STARTED. NO PATIENT WAS INVOLVED IN THIS CASE.
Patient problems: Not Applicable
MAUDE report 6331302 ↗
MalfunctionJan 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE USER REPORTED THAT "THE VOLUME WAS NOT WORKING." THE DEVICE HAD A SPEAKER ISSUE. NO PATIENT WAS INVOLVED IN THIS CASE.
Patient problems: Not Applicable
MAUDE report 6258343 ↗
MalfunctionJan 11, 2017Infusion or Flow Problem; Infusion or Flow Problem
THE USER REPORTED THE PUMP WAS INFUSING SLOWER THAN ANTICIPATED. NO PATIENT INJURY OR HARM WAS INVOLVED IN THIS CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6244007 ↗
MalfunctionJan 11, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE USER REPORTED "THE DEVICE IS NOT MAKING ANY SOUND. NO BEEPS, CHIRPS OR ANYTHING ELSE". NO PATIENT WAS INVOLVED IN THIS CASE.
Patient problems: Not Applicable
MAUDE report 6243907 ↗

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-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-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
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	`00814371020020`
Brand	Z-800W
Model	Z-800W
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 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.

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