Zyno Medical Recalls
16 recalls on record · April 10, 2013 to June 18, 2025 · Medical Devices
Recalls by year
13
16
19
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 18, 2025Medical DevicesFDA
Zyno Medical LLC recalls Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a p
Hazard: Unreleased software versions were installed on distributed devices without verification or validation.
June 18, 2025Medical DevicesFDA
Zyno Medical LLC recalls Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a pa
Hazard: Unreleased software versions were installed on distributed devices without verification or validation.
June 18, 2025Medical DevicesFDA
Zyno Medical LLC recalls Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a pa
Hazard: Unreleased software versions were installed on distributed devices without verification or validation.
June 18, 2025Medical DevicesFDA
Zyno Medical LLC recalls Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a pat
Hazard: Unreleased software versions were installed on distributed devices without verification or validation.
December 4, 2024Medical DevicesFDA
Zyno Medical LLC recalls Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is i
Hazard: 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.
November 27, 2024Medical DevicesFDA
Zyno Medical LLC recalls Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended
Hazard: Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
October 16, 2024Medical DevicesFDA
Zyno Medical LLC recalls Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F
Hazard: There is a defect in the air-in-line software algorithm.
July 10, 2024Medical DevicesFDA
Zyno Medical LLC recalls Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
Hazard: 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.
March 6, 2024Medical DevicesFDA
Zyno Medical LLC recalls Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and
Hazard: 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
July 31, 2019Medical DevicesFDA
Zyno Medical LLC recalls Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or G
Hazard: Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified
July 31, 2019Medical DevicesFDA
Zyno Medical LLC recalls Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gr
Hazard: Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified
October 5, 2016Medical DevicesFDA
Zyno Medical LLC recalls Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-
Hazard: Administration Set potential filter leaking
October 5, 2016Medical DevicesFDA
Zyno Medical LLC recalls Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2
Hazard: Administration Set potential filter leaking
October 5, 2016Medical DevicesFDA
Zyno Medical LLC recalls Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2
Hazard: Administration Set potential filter leaking
October 5, 2016Medical DevicesFDA
Zyno Medical LLC recalls Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A
Hazard: Administration Set potential filter leaking
April 10, 2013Medical DevicesFDA
Zyno Medical LLC recalls Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human
Hazard: Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump