Zyno Medical LLC: Medical Device Recall in 2024 - (Recall #: Z-0506-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: October 18, 2024

Date Posted: November 27, 2024

Recall Number: Z-0506-2025

Event ID: 95601

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.

Status: Ongoing

Product Quantity: 34,994 units

Code Information:

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.

Distribution Pattern:

This product is distributed only in the United States.

Voluntary or Mandated:

Voluntary: Firm initiated