Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Zyno Medical with 16 device recalls, 7 510(k) clearances and 1 warning letter. The most recent is a device recall dated May 7, 2025: Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, bl….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 7, 2025 | Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.Class I · Unreleased software versions were installed on distributed devices without verification or validation. | Device recalls |
| May 7, 2025 | Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.Class I · Unreleased software versions were installed on distributed devices without verification or validation. | Device recalls |
| May 7, 2025 | Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.Class I · Unreleased software versions were installed on distributed devices without verification or validation. | Device recalls |
| May 7, 2025 | Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.Class I · Unreleased software versions were installed on distributed devices without verification or validation. | Device recalls |
| Oct 18, 2024 | Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenoClass II · Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being | Device recalls |
| Sep 30, 2024 | Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide iClass III · For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance wi | Device recalls |
| Sep 13, 2024 | 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;Class I · There is a defect in the air-in-line software algorithm. | Device recalls |
| Jun 4, 2024 | Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion PumpsClass II · Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not | Device recalls |
| Dec 3, 2018 | Warning letter: UnspecifiedCDRH | Warning letters |
| Aug 30, 2016 | Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)K153193 · FRN | 510(k) clearances |
| Oct 17, 2014 | HALO AMBULATORY INFUSION SYSTEMK140783 · FRN | 510(k) clearances |
| Jan 23, 2014 | ZYNO MEDICAL ADMINISTRATION SETK132841 · FPA | 510(k) clearances |
| Jun 12, 2013 | Z-800 INFUSION SYSTEMK130690 · FRN | 510(k) clearances |
| Sep 7, 2012 | ZYNO MEDICAL ADMINISTRATION SETK120685 · FPA | 510(k) clearances |
| Jul 8, 2010 | ZYNO Z-800 INFUSION SYSTEM MODEL Z-800K100705 · FRN | 510(k) clearances |
| Oct 31, 2007 | Z-800 VOLUMETRIC INFUSION PUMPK071545 · FRN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
