Z-800W Infusion System (Zyno Medical) – Unreleased Software (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Brand
Zyno Medical LLC
Lot Codes / Batch 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.
Products Sold
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.
Zyno Medical LLC is recalling Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and bl due to Unreleased software versions were installed on distributed devices without verification or validation.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Unreleased software versions were installed on distributed devices without verification or validation.
Recommended Action
Per FDA guidance
Consignees received an "URGENT: MEDICAL DEVICE CORRECTION" notification dated 5/7/25 by email. The notification instructs consignees to check their stock for affected devices and to immediately stop use; recalled devices are to be returned to Zyno Medical via the provided Response Verification Form. The recall notice is to be provided to personnel at consignee locations who need to be informed and communicated to facilities to where devices were transferred to. Any questions about this recall action are to be directed via email to Frederick Lee at feedback@intuvie.com. A representative from Zyno Medical s partner company, Intuvie LLC, will be in contact with you to coordinate instructions on exchanging devices to remediate this action.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026