FDAFDA · Food and drugs·Recall number Z-1865-2025
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Published June 18, 2025 · Recall initiated: May 7, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Unreleased software versions were installed on distributed devices without verification or validation.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Zyno Medical LLC
- Distributor
- US Nationwide
- Lot
- Lot Code: Model Number; Z800; UDI-DI: 00814377102006; Serial No.: 800242; 801925; 802867; 900875; 901058; 901089; 901101; 901126; 901143; 901567; 904021; 904073; 800378; 801950; 803020; 900914; 901061; 901090; 901102; 901129; 901145; 901795; 904023; 904083; 801082; 802113; 803268; 900961; 901066; 901091; 901103; 901130; 901230; 904004; 904026; 904087; 801353; 802131; 803526; 900964; 901070; 901092; 901110; 901131; 901240; 904006; 904027; 904093; 801420; 802160; 803768; 901001; 901076; 901093; 901112; 901132; 901241; 904007; 904028; 904094; 801503; 802645; 900029; 901014; 901077; 901094; 901113; 901133; 901244; 904009; 904029; 905077; 801601; 802753; 900035; 901024; 901081; 901095; 901115; 901134; 901245; 904011; 904030; 905162; 801640; 802764; 900051; 901041; 901083; 901096; 901116; 901136; 901246; 904012; 904031; 906681; 801852; 802771; 900115; 901054; 901085; 901097; 901117; 901138; 901249; 904013; 904038; 906692; 801855; 802774; 900133; 901055; 901086; 901098; 901118; 901140; 901250; 904014; 904040; 906693; 801881; 802780; 900147; 901056; 901087; 901099; 901119; 901141; 901252; 904018; 904042; 906716; 801884; 802798; 900569; 901057; 901088; 901100; 901123; 901142; 901255; 904020; 904053; 906720;906721.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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