Natick, MA, United States
Zyno Medical LLC recalls
7 recalls recorded since 2018, most recently on 7 May 2025. 6 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)6
Terminated or completed1
Class I (FDA)2
Ongoing Class I Medical devices
- Recall started
- 7 May 2025
- Reason
- Unreleased software versions were installed on distributed devices without verification or validation.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1865-2025, Z-1868-2025, Z-1867-2025, Z-1866-2025
- Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
- Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
- Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
- Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Ongoing Class II Medical devices
- Recall started
- 18 October 2024
- Reason
- Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
- Distribution
- This product is distributed only in the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0506-2025
- 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, and blood products to a patient under t
Ongoing Class III Medical devices
- Recall started
- 30 September 2024
- Reason
- 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.
- Distribution
- Domestic: AL, FL, LA, MI, NE, NJ, OH, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0523-2025
- 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, blood, and blood products to a patient
Ongoing Class I Medical devices
- Recall started
- 13 September 2024
- Reason
- There is a defect in the air-in-line software algorithm.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0005-2025
- 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 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Ongoing Class II Medical devices
- Recall started
- 4 June 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2263-2024
- Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
Ongoing Class II Medical devices
- Recall started
- 20 December 2023
- Reason
- 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
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1183-2024
- 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 supervision of physician or other certified healt
Terminated Class II Medical devices
- Recall started
- 29 May 2019
- Terminated
- 22 June 2020
- Reason
- 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
- Distribution
- MA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2059-2019, Z-2058-2019
- Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F
- Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.