Zyno Medical LLC
FDA Regulatory Profile
Zyno Medical LLC appears in FDA public data with 16 recalls — including 5 Class I (most serious) —, 7 510(k) clearances, 7 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-1867-2025, Class I) was initiated on May 7, 2025. Its most recent 510(k) clearance was granted on August 30, 2016.
Summary
- Total Recalls
- 16 (5 Class I)
- 510(k) Clearances
- 7
- Inspections
- 7
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1867-2025 | Class I | Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and bl | May 7, 2025 |
| Z-1865-2025 | Class I | Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blo | May 7, 2025 |
| Z-1866-2025 | Class I | Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and bl | May 7, 2025 |
| Z-1868-2025 | Class I | Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and b | May 7, 2025 |
| Z-0506-2025 | Class II | Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion | October 18, 2024 |
| Z-0523-2025 | Class III | Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 | September 30, 2024 |
| Z-0005-2025 | Class I | Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 | September 13, 2024 |
| Z-2263-2024 | Class II | Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps | June 4, 2024 |
| Z-1183-2024 | Class II | Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parentera | December 20, 2023 |
| Z-2059-2019 | Class II | Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical | May 29, 2019 |
| Z-2058-2019 | Class II | Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical | May 29, 2019 |
| Z-2896-2016 | Class II | Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Fee | July 29, 2016 |
| Z-2893-2016 | Class II | Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity F | July 29, 2016 |
| Z-2895-2016 | Class II | Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Fe | July 29, 2016 |
| Z-2894-2016 | Class II | Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Fe | July 29, 2016 |
| Z-1024-2013 | Class II | Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood | June 13, 2011 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K153193 | Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA | August 30, 2016 |
| K140783 | HALO AMBULATORY INFUSION SYSTEM | October 17, 2014 |
| K132841 | ZYNO MEDICAL ADMINISTRATION SET | January 23, 2014 |
| K130690 | Z-800 INFUSION SYSTEM | June 12, 2013 |
| K120685 | ZYNO MEDICAL ADMINISTRATION SET | September 7, 2012 |
| K100705 | ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 | July 8, 2010 |
| K071545 | Z-800 VOLUMETRIC INFUSION PUMP | October 31, 2007 |