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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this as a Class I recall. Per the rubric, FDA Class I recalls cannot be scored below 4. The unverified software on a critical infusion device poses significant risk of harm to patients receiving intravenous therapy.
Plain-English summary
Zyno Medical LLC is recalling 613 units of the Z-800WF Infusion System, a device intended to provide intravenous infusion of parenteral fluids, blood, and blood products to patients. The recall was initiated because unreleased software versions were installed on the distributed devices without verification or validation.
The affected devices have Model No. Z800WF, UDI-DI 00814371020037, and serial numbers 500004, 500005, 500006, 500810, 500812, 500813, 501748, 503680, 503681, and 503682. Distribution was nationwide in the United States.
Patients and healthcare providers in possession of an affected Z-800WF Infusion System should stop use immediately and contact Zyno Medical LLC for instructions on replacement or remediation of the device.
The recalled product
- Product
- Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
- Manufacturer
- Zyno Medical LLC
- Category
- Medical Device — Infusion System
- Affected units
- 613
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Model No. Z800WF
- UDI-DI: 00814371020037
- Serial No. 500004
- 500005
- 500006
- 500810
- 500812
- 500813
- 501748
- 503680
- 503681
- 503682.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Zyno Medical LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Zyno Medical LLC
See all →- SevereZ-800 Infusion System recalled for unverified software installation
FDA (Devices) · 2025-06-18
- SevereZ-800F Infusion System Recall Due to Unvalidated Software Versions
FDA (Devices) · 2025-06-18
- SevereZ-800W Infusion System Recalled for Unvalidated Software Installation
FDA (Devices) · 2025-06-18
- ModerateZ-800WF Infusion Pumps Recalled for Software Incompatibility Issue
FDA (Devices) · 2024-12-04
- HighZ-800 Infusion System Recalled for Battery Depletion Risk
FDA (Devices) · 2024-11-27
Same hazard · software defect
See all →- SevereMedtronic MiniMed Go App Recall for Insulin Dose Reminder Failure
FDA (Devices) · 2026-10-28
- SeverePhilips Lumify Diagnostic Ultrasound System Recalled for Connection Issues
FDA (Devices) · 2026-10-28
- ModerateIntelerad IntelePACS Software Recalled for Image Display Mismatch
FDA (Devices) · 2026-10-21
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateZ-800WF Infusion Pumps Recalled for Software Incompatibility Issue
FDA (Devices) · 2024-12-04
- ModerateZyno Medical Recalls Z-800 Volumetric Infusion Systems for Software Update
FDA (Devices) · 2013-04-10
- CriticalZ-800 Infusion System Recalled for Air-in-Line Software Algorithm Defect
FDA (Devices) · 2024-10-16
- HighZ-800 Infusion System Recalled for Battery Depletion Risk
FDA (Devices) · 2024-11-27
- HighInfusion Pumps Model Z-800WF Recalled Due to Alarm Volume Malfunction
FDA (Devices) · 2024-03-06
- HighZyno Medical Z800 Series Infusion Pumps: Faulty Power Supply May Prevent Battery Charging
FDA (Devices) · 2024-07-10