Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

Class I - Dangerous

🏥 Medical Devices Recalled: May 7, 2025 Zyno Medical Infusion Pumps Nationwide

What Should You Do?

Check if you have this product:
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.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Zyno Medical LLC
Reason for Recall:: Unreleased software versions were installed on distributed devices without verification or validation.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

Product Codes/Lot Numbers:

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.