The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0506-2025·Announced 2024-11-27

Z-800 Infusion System Recalled for Battery Depletion Risk

Zyno Medical is recalling 34,994 units of the Z-800 Infusion System due to battery depletion risk from self-discharge and parasitic leakage current. The battery may not retain charge despite continuous AC power, potentially affecting device operation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II recall of a medical device that presents a risk of harm through device malfunction. No reported injuries or deaths. This qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Zyno Medical LLC is recalling 34,994 units of the Z-800 Infusion System models Z-800, Z-800F, Z-800W, and Z-800WF. The Z-800 is used to deliver intravenous infusion of parenteral fluids, blood, and blood products under medical supervision.

The recall is due to a potential battery defect. The device's battery may deplete over time due to self-discharge and internal parasitic leakage current, even when continuously plugged into AC mains power. This could result in loss of backup power and device malfunction if AC mains power is interrupted.

The affected units are distributed in the United States only. The recall involves specific lot codes identified by Zyno Medical and the FDA.

Patients and healthcare providers using the Z-800 should contact Zyno Medical LLC or consult the FDA recall notice for replacement or repair instructions.

The recalled product

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…
Manufacturer
Zyno Medical LLC
Category
Medical Device — Infusion System
Hazard
Affected units
34,994

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distribution scope not specified by the agency.

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