Z-1868-2025Class I

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

Name: Z-1868-2025 Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood...
Creator: Zyno Medical LLC
Published: 2025-05-07
License: https://open.fda.gov/license/

Zyno Medical LLC. / initiated 2025-05-07 / Open, Classified / root cause: software

FDA source

Zyno Medical LLC began a recall of Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient on 2025-05-07. FDA classified it as Class I and gives the reason as "Unreleased software versions were installed on distributed devices without verification or validation". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1868-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-05-07
Posted: 2025-06-06
Recalling firm: Zyno Medical LLC.
Product: Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Product code: FRN Pump, Infusion
Reason for recall: Unreleased software versions were installed on distributed devices without verification or validation.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: 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 [email protected]. 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.
Quantity in commerce: 613 units
Distribution: US Nationwide
Product codes and lots: Model No. Z800WF; UDI-DI: 00814371020037; Serial No. 500004; 500005; 500006; 500810; 500812; 500813; 501748; 503680; 503681; 503682.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1868-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1865-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-06
Z-1866-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-06
Z-1867-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-06
Z-1868-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-06

Product code FRN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)