Z-800W Infusion System Recalled for Unverified Software Installation
Zyno Medical LLC is recalling 613 Z-800W Infusion Systems distributed nationwide after unreleased software versions were installed without verification or validation. The FDA classified this as a Class I recall due to potential safety risks.
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: FDA Class I classification mandates a minimum severity score of 4. The recall concerns unverified software on distributed infusion devices with potential for serious patient harm, though no illnesses or injuries have been reported.
Plain-English summary
The Z-800W Infusion System is a medical device intended to provide intravenous infusion of parenteral fluids, blood, and blood products to patients. Zyno Medical LLC has recalled 613 units of this device distributed nationwide across the United States.
The devices were found to have unreleased software versions installed without verification or validation. This quality control failure means the software was not properly tested or approved before deployment to clinical use. The presence of unverified software on distributed devices creates potential risks to patient safety.
Healthcare facilities and providers who received affected Z-800W Infusion Systems should immediately stop using the recalled units and contact Zyno Medical LLC for instructions. The devices are identifiable by Model Number Z800W and the specific serial numbers listed in FDA recall notice Z-1867-2025.
Patients currently using these devices or those who may have been treated with them should consult with their healthcare providers to discuss any concerns about their infusion therapy.
The recalled product
- Product
- Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
- Manufacturer
- Zyno Medical LLC
- Hazard
- unverified-software
- device-malfunction
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 (20)
- Model Number: Z800W
- UDI-DI
- 00814371020020
- Serial No. 700063
- 700163
- 700203
- 700402
- 700488
- 700093
- 700169
- 700210
- 700428
- 700495
- 700104
- 700172
- 700214
- 700431
- 700503
- 700111
- 700188
Distribution
Distributed nationwide across the United States.
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