Z-800W 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:
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; 700225; 700440; 700510; 700120; 700189; 700230; 700449; 700513; 700135; 700190; 700285; 700460; 700541; 700145; 700192; 700375; 700471; 700481; 700150; 700195; 700391; 700472; 700397; 700159; 700199; 700393; 700478; 700201; 700162.
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-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

Product Codes/Lot Numbers:

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; 700225; 700440; 700510; 700120; 700189; 700230; 700449; 700513; 700135; 700190; 700285; 700460; 700541; 700145; 700192; 700375; 700471; 700481; 700150; 700195; 700391; 700472; 700397; 700159; 700199; 700393; 700478; 700201; 700162.