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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

Zyno Medical Z-800 Infusion Systems Recalled for Battery Power Failure

Agency Publication Date: November 21, 2024
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Summary

Zyno Medical LLC has recalled approximately 34,994 units of the Z-800 Infusion System, specifically models Z-800, Z-800F, Z-800W, and Z-800WF. These devices are used by healthcare professionals to deliver fluids, blood, and blood products intravenously to patients. The recall was issued because the system's battery may deplete over time due to internal power leakage even when plugged into an electrical outlet, which could lead to unexpected power failure. No injuries or incidents have been reported to date.

Risk

A depleted battery can cause the infusion system to shut down without warning, even while connected to mains power. This failure could interrupt critical medical treatments or fluid delivery, potentially causing serious health complications for patients undergoing supervised care.

What You Should Do

  1. This recall affects the Zyno Medical Z-800 Infusion System, including model and catalog numbers Z-800, Z-800F, Z-800W, and Z-800WF.
  2. Check your device's lot code against the list of affected production batches. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact Zyno Medical LLC or your authorized medical distributor to arrange for the return, replacement, or correction of the device.
  5. For additional questions, call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Z-800 Infusion System
Model / REF:
Z-800
Z-800F
Z-800W
Z-800WF
Lot Numbers:
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

Intended for intravenous infusion of parenteral fluids, blood, and blood products.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95601
Status: Active
Manufacturer: Zyno Medical LLC
Sold By: Authorized medical distributors; Hospitals; Clinics
Manufactured In: United States
Units Affected: 34,994 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.