Z-800Recalls & reported problems

Summary

The FDA's MAUDE database contains 258 adverse event reports that list this exact device (DI 00814371020006), received between Dec 20, 2016 and Mar 5, 2024 — classified as 258 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (206 reports).

2 FDA recall records name this device's identifier, 2 still open.

7 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

1. Sep 30, 2024Open, Classified

   For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.

   Z-0523-2025 · Root cause: Software design (manufacturing process) · FDA record ↗

2. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 258 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2024Device Sensing Problem; Device Sensing Problem

  ON (B)(6) 2022 ZYNO SOLUTIONS RECEIVED AN EMAIL STATING THAT PUMP (B)(6) WAS RETURNED TO HER AND IT HAD A NOTE ON THE PUMP THAT STATED "OCCLUSION." OPERATOR RN. MEDICATION N/A. PATIENT INVOLVED. PATIENT WAS NOT HARMED. EVENT DATE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842327 ↗
• MalfunctionMar 5, 2024No Audible Alarm; No Audible Alarm

  ON 10/7/2021 ZYNO SOLUTIONS RECEIVED AN STATING THAT PUMP (B)(6) DOES NOT ALARM WHEN AN INFUSION IS COMPLETE. OPERATOR BIOMED TECH. MEDICATION N/A. NO PATIENT INVOLVED, PATIENT NOT HARMED. (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838890 ↗
• MalfunctionMar 5, 2024Device Alarm System; Device Alarm System

  ZYNO MEDICAL RECEIVED A REPORT THAT A PUMP HAD A NOTE THAT JUST STATED "AIR IN LINE" INDICATING AN UNKNOWN ISSUE WITH THE AIR-IN-LINE SENSOR. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838582 ↗
• MalfunctionMar 1, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2021-00010).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11394416 ↗
• MalfunctionFeb 26, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2021-00008).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388802 ↗
• MalfunctionFeb 26, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2021-00009).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388752 ↗
• MalfunctionFeb 17, 2021Insufficient Flow or Under Infusion

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2021-00005).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11338743 ↗
• MalfunctionFeb 17, 2021Insufficient Flow or Under Infusion

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2021-00006).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11338738 ↗
• MalfunctionDec 17, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2020-00053).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11032538 ↗
• MalfunctionDec 9, 2020Device Alarm System; Excess Flow or Over-Infusion; Device Alarm System; Excess Flow or Over-Infusion

  ON 11/23/2020, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR ON 12/03/2019 AND STATED THAT A PUMP 901717 WOULD NOT OCCLUDE AND THE VOLUME INFUSION WAS TOO HIGH. THERE WAS NO PATIENT INVOLVEMENT. NO INFORMATION WAS PROVIDED FOR THE DEVICE OPERATOR OR THE MEDICATION BEING INFUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10978852 ↗
• MalfunctionDec 9, 2020Device Alarm System; Device Alarm System

  ON 11/23/2020, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR ON 11/20/2020, AND STATED THAT PUMP# (B)(4) WILL NOT OCCLUDE. THE DEVICE OPERATOR WAS A BIOMED TECHNICIAN. NO MEDICATION WAS BEING INFUSED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10978849 ↗
• MalfunctionDec 9, 2020Device Alarm System; Device Alarm System

  ON 11/23/2020, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A TECHNICIAN FOUND PUMP (B)(4) HAD AIR IN LINE ISSUES DURING A FIELD PREVENTATIVE MAINTENANCE ON 04/01/2020. THERE WAS NO PATIENT INVOLVEMENT. NO MEDICATION WAS BEING INFUSED. THE DEVICE OPERATOR WAS THE TECHNICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10978778 ↗
• MalfunctionDec 9, 2020Device Alarm System; Device Alarm System

  ON 11/23/2020, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A TECHNICIAN FOUND PUMP (B)(4) HAD AIR IN LINE ISSUES DURING A FIELD PREVENTATIVE MAINTENANCE ON (B)(6) 2019. THERE WAS NO PATIENT INVOLVEMENT. NO MEDICATION WAS BEING INFUSED. THE DEVICE OPERATOR WAS THE TECHNICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10978764 ↗
• MalfunctionOct 8, 2020Inaccurate Flow Rate; Improper Flow or Infusion; Infusion or Flow Problem; Inaccurate Flow Rate; Improper Flow or Infusion; Infusion or Flow Problem

  ON (B)(6) 2020, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR ON 03/14/2019, AND STATED THAT ONE OF HER NURSES WAS INFUSING SALINE, AND THE TIME THAT WAS SET WAS DIFFERENT FROM THE ACTUAL AMOUNT OF TIME THE INFUSION TOOK. SHE STATED THERE WAS NO ONE HARMED. SHE STATED THE ASSUMPTION IS THAT THE TIME IS SLOWER BY 30 MIN THAN IT SHOULD BE. EVENT DATE WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10650046 ↗
• MalfunctionOct 8, 2020Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow

  ON (B)(6) 2020, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR ON 04/03/2019, AND STATED THAT "PUMP 905282 CAME BACK FROM A FACILITY WITH A NOTE THAT SAID OCCLUSION". EVENT DATE IS UNKNOWN. THE OPERATOR OF THE DEVICE IS UNKNOWN. IT IS UNKNOWN IF THERE WAS A PATIENT INVOLVED OR NOT. THERE WAS NO PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10650043 ↗
• MalfunctionOct 6, 2020Improper Flow or Infusion; Improper Flow or Infusion

  ON 09/17/2020, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR ON (B)(6) 2018, AND REPORTED THAT THE PUMP 903252 WAS RUNNING AT 27 ML/HR THEN STOPPED ON ITS OWN, AND THEN STARTED RUNNING AT 500ML/HR. THERE WAS NO PATIENT INJURY OR HARM. NO INFORMATION WAS PROVIDED FOR THE MEDICATION BEING INFUSED. THE OPERATER OF THE DEVICE WAS A NURSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10635294 ↗
• MalfunctionAug 27, 2019Excess Flow or Over-Infusion; Infusion or Flow Problem; Excess Flow or Over-Infusion; Infusion or Flow Problem

  ON 8/22/2019, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A FLOW RATE ISSUE OF THE PUMP. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR ON 8/22/2019, STATING THAT "PUMP (B)(4) WAS INFUSING TOO QUICKLY." SHE STATED "SOMETIMES IT SAYS THERE'S MORE IN THE BAG THAN THERE ACTUALLY IS." SHE ALSO STATED THAT "SOMETIMES THE PUMP WOULD COMPLETE AN INFUSION AND THERE WOULD STILL BE A SIGNIFICANT AMOUNT OF MEDICATION LEFT IN THE BAG." MEDICATION USED WAS GAMMAKED. A PATIENT WAS INVOLVED, BUT THERE WAS NO HARM. THE DEVICE OPERATOR WAS A REGISTERED NURSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8936114 ↗
• MalfunctionAug 27, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2019-00024).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8936109 ↗
• MalfunctionJun 6, 2019Device Alarm System; Defective Alarm; Protective Measures Problem; Device Alarm System; Defective Alarm; Protective Measures Problem

  ON (B)(6) 2019 ZYNO MEDICAL RECEIVED A MISSED OCCLUSION ALARM ISSUE OF INFUSION PUMP FROM A DISTRIBUTOR REPRESENTATIVE. THE DISTRIBUTOR FORWARDED THE INFORMATION FROM A USER FACILITY REPRESENTATIVE: "PUMP SERIAL # (B)(4) WOULD NOT ALARM OCCLUSION EVEN WITH CLAMP ON TUBING. NO PATIENT HARMED. NOTICED BY RN. MEDICATION SIMPONI ARIA." NO INFORMATION ON PATIENT GENDER WAS RECEIVED BY ZYNO MEDICAL. THE DISTRIBUTOR ALSO PROVIDED THE LAST DATE OF PERIODIC MAINTENANCE OF THIS DEVICE AS 06/05/2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8674692 ↗
• MalfunctionDec 19, 2018Free or Unrestricted Flow; Free or Unrestricted Flow

  A DISTRIBUTOR REPORTED A FREE FLOW ISSUE TO ZYNO MEDICAL ON (B)(6) 2018. THE DISTRIBUTOR RECEIVED AN EMAIL FROM THE INITIAL REPORTER ON (B)(6) 2018, STATING THAT THE AFFECTED PUMP WAS FREE FLOWING DURING TESTING. NO PATIENT WAS INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8178598 ↗
• MalfunctionOct 23, 2018Insufficient Flow or Under Infusion; Infusion or Flow Problem; Insufficient Flow or Under Infusion; Infusion or Flow Problem

  THIS IS THE FOLLOW UP REPORT FOR THE INITIALLY SUBMITTED MDR (3006575795-2018-00066).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7996422 ↗
• MalfunctionAug 1, 2018Excess Flow or Over-Infusion; Improper Flow or Infusion; Infusion or Flow Problem; Excess Flow or Over-Infusion; Improper Flow or Infusion; Infusion or Flow Problem

  THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2018-00057).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7740958 ↗
• MalfunctionJun 18, 2018Inaccurate Flow Rate; Device Operates Differently Than Expected; Inaccurate Flow Rate; Device Operates Differently Than Expected

  A DISTRIBUTOR REPORTED AN OVER-INFUSION ISSUE TO ZYNO MEDICAL ON (B)(6) 2018. THE END USER REPORTED TO THE DISTRIBUTOR THAT THE AFFECTED PUMP WAS SET FOR AN INFUSION FOR TWO HOURS BUT COMPLETED THE INFUSION IN ONLY AN HOUR. WHEN THE DISTRIBUTOR RECEIVED THE PUMP, THE PUMP WAS TESTED FOR 3 TIMES, SOMETIMES WITHIN SPECIFICATION AND OTHER TIMES HAD A FLOW RATE TWICE AS FAST. NO PATIENT INJURY WAS REPORTED FOR THIS CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7611768 ↗
• MalfunctionJun 15, 2018No Audible Alarm; Failure to Infuse; Device Operates Differently Than Expected; No Flow; No Audible Alarm; Failure to Infuse; Device Operates Differently Than Expected; No Flow

  A USER FACILITY REPRESENTATIVE REPORTED A FLOW ISSUE WITH THE DEVICE TO ZYNO MEDICAL ON (B)(6) 2018. THE USER FACILITY REPRESENTATIVE STATED THAT THE TUBING WAS CLAMPED AND THE PUMP ACTED LIKE INFUSING WITH A DISPLAYED VOLUME DECREASING, BUT NOTHING WAS INFUSED: "THE REASON WE ARE HAVING TO USE A CLAMP ABOVE THE UNIT IS THAT WHEN ARE RUNNING A SECONDARY, INSTEAD OF THE PRIMARY STOPPING IT IS STILL PULLING FROM THE PRIMARY BAG AND SENDING IT UP INTO THE SECONDARY BAG- SO WE HAVE TO USE A CLAMP ON THE PRIMARY LINE DURING THE INFUSION OF THE SECONDARY BAG. THIS OCCURS ON ALL OF OUR PUMPS. MY EXPERIENCE IN THE PAST WITH OTHER PUMPS HAS BEEN THAT ONCE YOU START A SECONDARY INFUSING THE PRIMARY STOPS RUNNING." THE USER FACILITY FORWARDED THE ORIGINAL DESCRIPTION INFORMATION FROM THE NURSE ON (B)(6) 2018: "WHEN BOTH LINES ARE CLAMPED PUMP WILL NOT ALARM IT WILL JUST ACT AS THOUGH SOMETHING IS INFUSING. THE NUMBERS ON PUMP WILL DECREASE VOLUME AMOUNT BUT NO MEDS INFUSING. ITS PUMP NUMBER 905212". THE USER FACILITY ALSO REPORTED THAT "THE PUMP IS COUNTING DOWN MEDICATION BEING GIVEN AND THERE WAS NOTHING GOING THROUGH THE LINE. ONE INSTANCE THE LINE WAS CLAMPED AND IT KEPT COUNTING DOWN LIK

  Patient problems: Blood Loss

  MAUDE report 7607241 ↗
• MalfunctionJun 12, 2018Inaccurate Flow Rate; Device Operates Differently Than Expected; Electrical Power Problem; Inaccurate Flow Rate; Device Operates Differently Than Expected; Electrical Power Problem

  THE CUSTOMER REPORTED FLOW RATE ISSUE AND POWER ISSUE WITH THE DEVICE. "THE PUMP JUST FLASHED AND CHANGED THE RATE IN 2 SECONDS, AND THEN COMPLETELY WIPED IT TO ZERO." "IT BEEPS WHEN OFF. TURNS ITSELF OFF THEN ON AGAIN AND CHANGES THE RATES ON ITS OWN." NO PATIENT WAS INVOLVED IN THIS CASE.

  Patient problems: No Patient Involvement

  MAUDE report 7593074 ↗

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-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-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-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-2263-2024 · Jun 4, 2024 · Open, Classified
  Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
• 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