The Recall Desk

Manufacturer

Zyno Medical LLC

16 recalls in our database name Zyno Medical LLC as the manufacturing or recalling firm.

What the numbers show

Total
16
Critical
1
Severe
5
Most recent
2025-06-18

Of the 16 recalls from Zyno Medical LLC we have scored against our rubric, 1 (6%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (31%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–16 of 16

  • SevereFDA (Devices)·Z-1868-2025·2025-06-18

    Z-800WF Infusion System software verification defect recall

    Zyno Medical LLC is recalling 613 units of the Z-800WF Infusion System because unreleased software versions were installed on distributed devices without verification or validation.

    Product
    Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1865-2025·2025-06-18

    Z-800 Infusion System recalled for unverified software installation

    Zyno Medical LLC is recalling 613 units of the Z-800 Infusion System distributed nationwide because unreleased software versions were installed on the devices without verification or validation.

    Product
    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1867-2025·2025-06-18

    Z-800W Infusion System Recalled for Unvalidated Software Installation

    Zyno Medical LLC is recalling the Z-800W Infusion System because unreleased software versions were installed on devices without verification or validation.

    Product
    Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1866-2025·2025-06-18

    Z-800F Infusion System Recall Due to Unvalidated Software Versions

    Zyno Medical LLC is recalling the Z-800F Infusion System because unreleased software versions were installed on distributed devices without verification or validation. This poses a risk to patients receiving intravenous infusion therapy.

    Product
    Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0523-2025·2024-12-04

    Z-800WF Infusion Pumps Recalled for Software Incompatibility Issue

    Zyno Medical LLC is recalling Z-800WF infusion pumps due to incompatibility between WiFi software and the pump's operating software. The affected units were distributed in eight U.S. states.

    Product
    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 under the direction or supervision physician or other certi
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0506-2025·2024-11-27

    Z-800 Infusion System Recalled for Battery Depletion Risk

    Zyno Medical is recalling 34,994 units of the Z-800 Infusion System due to battery depletion risk from self-discharge and parasitic leakage current. The battery may not retain charge despite continuous AC power, potentially affecting device operation.

    Product
    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 the direction or supervision of a physician or other certifie
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0005-2025·2024-10-16

    Z-800 Infusion System Recalled for Air-in-Line Software Algorithm Defect

    Zyno Medical LLC is recalling the Z-800 Infusion System due to a defect in the air-in-line software algorithm. Approximately 34,994 units distributed nationwide are affected by this Class I FDA recall.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2263-2024·2024-07-10

    Zyno Medical Z800 Series Infusion Pumps: Faulty Power Supply May Prevent Battery Charging

    Certain Zyno Medical Z800 series infusion pumps contain faulty power supply modules that cannot charge the rechargeable battery. When unplugged from AC power, affected pumps may lack sufficient charge to operate.

    Product
    Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1183-2024·2024-03-06

    Infusion Pumps Model Z-800WF Recalled Due to Alarm Volume Malfunction

    Zyno Medical recalls Z800 infusion pumps (Model Z-800WF) with software version 5.2.05 due to a potential alarm volume malfunction. The alarm may revert to low volume, delaying therapy and risking organ failure in extreme cases.

    Product
    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 health care professional Model: Z-800WF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2058-2019·2019-07-31

    Zyno Medical Administration Sets Recalled Due to Inverted Pinch Clamp Defect

    Zyno Medical LLC is recalling administration sets with inverted pinch clamps that may cause blood to be drawn from patients instead of delivering fluid.

    Product
    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
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2059-2019·2019-07-31

    Zyno Medical Administration Sets Recalled Due to Inverted Pinch Clamp Defect

    Zyno Medical LLC is recalling administration sets where an inverted pinch clamp may cause blood to be drawn from the patient instead of delivering fluid.

    Product
    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
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2896-2016·2016-10-05

    Zyno Medical Administration Set Recalled for Potential Filter Leaking

    Zyno Medical LLC is recalling 47,989 sterile administration sets due to a potential filter leaking defect. The sets are used to administer fluids to patients.

    Product
    Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2894-2016·2016-10-05

    Zyno Medical Administration Set Recalled for Potential Filter Leaking

    Zyno Medical LLC is recalling 78,069 sterile administration sets because the filter may leak. The sets are used to administer fluids to patients.

    Product
    Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2895-2016·2016-10-05

    Zyno Medical Administration Set Recalled for Potential Filter Leaking

    Zyno Medical LLC is recalling 78,063 sterile administration sets due to a potential filter leaking defect. The sets are distributed nationwide for use with infusion pumps or gravity feed.

    Product
    Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Product Code: B2-70071-DF-120 (expanded recall) Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a conta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2893-2016·2016-10-05

    Zyno Medical Administration Set Recalled for Potential Filter Leaking

    Zyno Medical LLC is recalling 114,081 sterile administration sets due to a potential filter leaking defect. The sets are used to administer fluids to patients' vascular systems.

    Product
    Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Product Code: A2-80071-DF-120 (Expanded recall) Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a contai
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1024-2013·2013-04-10

    Zyno Medical Recalls Z-800 Volumetric Infusion Systems for Software Update

    Zyno Medical LLC is recalling 2,589 Z-800 Volumetric Infusion Systems to update the Preventative Maintenance schedule and add software to monitor fluid volume.

    Product
    Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Zyno Medical, LLC

Source: Wikidata (Q140608967), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.