Z-0506-2025Class II

Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is...

Name: Z-0506-2025 Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is...
Creator: Zyno Medical LLC
Published: 2024-10-18
License: https://open.fda.gov/license/

Zyno Medical LLC. / initiated 2024-10-18 / Open, Classified / root cause: design

FDA source

Zyno Medical LLC began a recall of Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of... on 2024-10-18. FDA classified it as Class II and gives the reason as "Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0506-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-18
Posted: 2024-11-21
Recalling firm: Zyno Medical LLC.
Product: Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.
Product code: FRN Pump, Infusion
Reason for recall: Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
Root cause tag: design
FDA root cause: Device Design
Action: Zyno Medical notified consignees on 10/18/2024 via email. Consignees were instructed that the updated notification supersedes current labeling and includes the following instructions: To maintain the health and runtime of the battery, it is recommended to plug the battery into AC Mains in for at least 6 hours every 30 days to fully charge the battery. Additionally, for scenarios where the Z800 pump is left plugged into AC Mains for extended periods of time, it is recommended to unplug for up to 5 seconds and re-plug the Z800 pump back into AC Mains at least every 30 days to activate the internal battery charger and ensure an expected operating time on battery power. Customers were also asked to provide acknowledgement of receipt.
Quantity in commerce: 34,994 units
Distribution: This product is distributed only in the United States.
Product codes and lots: Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF Lot Code: Lots: 201016280, 200515888, 200406416, 230920212, 200413400, 20040660, 200716968, 201016720, 20071632, 201211740, 201208256, 210319640, 210709900, 201211360, 2101221000, 210913560, 210913200, 231008352, 220205400, 220204548, 2211141000, 230206980, 230620800, 230420548, 230420136, 230525452, 230620200.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0506-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0506-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-21

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)