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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- software-defect
- unvalidated-release
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.
Related recalls
Same category
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22