Zyno Medical LLC.

Activity by year

Devices registered here (1)

• Set, Administration, Intravascular
  Product code FPA (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5440

Recalls & enforcement

• Class IOngoing2025-05-07
  Unreleased software versions were installed on distributed devices without verification or validation.
• Class IIOngoing2024-10-18
  Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
• Class IIIOngoing2024-09-30
  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.
• Class IOngoing2024-09-13
  There is a defect in the air-in-line software algorithm.
• Class IIOngoing2024-06-04
  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 unp…
• Class IIOngoing2023-12-20
  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 …
• Class IITerminated2019-05-29
  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 dr…
• Class IITerminated2016-07-29
  Administration Set potential filter leaking
• Class IITerminated2011-06-13
  Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump

FDA inspections (5)

• VAI2025-09-18
  Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
• VAI2023-08-16
  Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
• OAI2022-02-15
  Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
• VAI2017-12-15
  Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
• OAI2016-08-11
  Official Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (2)

• Warning Letter2022-07-12
  Warning Letter (opens in a new tab) · Natick Massachusetts
• Warning Letter2016-12-05
  Warning Letter (opens in a new tab) · Natick Massachusetts

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

• All facilities operated by Zyno Medical LLC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)