FDA Medical devices recall ·
Z-800WF Infusion System recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1868-2025
- Date
- (initiated May 7, 2025)
- Company / brand
- Zyno Medical LLC
177 Pine St, Natick, MA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 613 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Why was it recalled?
Unreleased software versions were installed on distributed devices without verification or validation.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. Z800WF; UDI-DI: 00814371020037; Serial No. 500004; 500005; 500006; 500810; 500812; 500813; 501748; 503680; 503681; 503682.
Distribution
US Nationwide
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1868-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.