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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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Critical RiskFDA Device
Medical Devices/Monitoring Devices

Zyno Medical LLC: Z-800 Infusion Systems Recalled for Air-In-Line Software Defect

Agency Publication Date: October 9, 2024
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Summary

Zyno Medical LLC has recalled 34,994 units of its Z-800 Infusion System series, including models Z-800, Z-800F, Z-800W, and Z-800WF, due to a software defect in the air-in-line detection algorithm. This flaw can prevent the system from properly identifying air bubbles in the infusion line, which could lead to medical complications for patients receiving intravenous treatments. The recall affects several software versions and specific lots distributed nationwide in the United States. Consumers and healthcare providers should contact the manufacturer for further instructions regarding the necessary software correction.

Risk

A defect in the software algorithm may fail to detect air in the infusion line, potentially allowing air to be delivered to a patient's bloodstream, which can cause serious injury or death.

What You Should Do

  1. Identify if you have an affected Z-800 Infusion System by checking the model number and software version: Models Z-800 (versions 6.1.01, 6-1.07z), Z-800F (4.1.02, 4.1.08z), Z-800W (3.1.32, 3.1.64z), or Z-800WF (3.1.32, 3.1.64z).
  2. Check your device for the following Lot Numbers: 190722360, 20110921-SH, 20111005-SH, 20111102-SH, 20111212-SH, 20120105-SH, 20120222-SH, 20120501-SH, 20120612-SH, 20120719-SH, 20120809-SH, 20190809-SH, 20120910-SH-1, 20121213-sh, 20130123-SH, 20130227-SH, 20120417-SH, 20130511-SH, 20130517-SH, 20130609-SH, 20130701-SH, 20130812-SH, or 20131024-SH.
  3. Verify the UDI-DI on the device label: Z-800 (00814371020006), Z-800W (00814371020020), Z-800F (00814371020013), or Z-800WF (00814371020037).
  4. Contact your healthcare provider or Zyno Medical LLC at their Natick, MA facility for further instructions and to coordinate the necessary software correction for your device.
  5. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer for software correction

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Z-800 Infusion System
Model / REF:
Z-800
Lot Numbers:
190722360
20110921-SH
20111005-SH
20111102-SH
20111212-SH
20120105-SH
20120222-SH
20120501-SH
20120612-SH
20120719-SH
20120809-SH
20190809-SH
20120910-SH-1
20121213-sh
20130123-SH
20130227-SH
20120417-SH
20130511-SH
20130517-SH
20130609-SH
20130701-SH
20130812-SH
20131024-SH
Product: Z-800F Infusion System
Model / REF:
Z-800F
Lot Numbers:
190722360
20110921-SH
20111005-SH
20111102-SH
20111212-SH
20120105-SH
20120222-SH
20120501-SH
20120612-SH
20120719-SH
20120809-SH
20190809-SH
20120910-SH-1
20121213-sh
20130123-SH
20130227-SH
20120417-SH
20130511-SH
20130517-SH
20130609-SH
20130701-SH
20130812-SH
20131024-SH
Product: Z-800W Infusion System
Model / REF:
Z-800W
Lot Numbers:
190722360
20110921-SH
20111005-SH
20111102-SH
20111212-SH
20120105-SH
20120222-SH
20120501-SH
20120612-SH
20120719-SH
20120809-SH
20190809-SH
20120910-SH-1
20121213-sh
20130123-SH
20130227-SH
20120417-SH
20130511-SH
20130517-SH
20130609-SH
20130701-SH
20130812-SH
20131024-SH
Product: Z-800WF Infusion System
Model / REF:
Z-800WF
Lot Numbers:
190722360
20110921-SH
20111005-SH
20111102-SH
20111212-SH
20120105-SH
20120222-SH
20120501-SH
20120612-SH
20120719-SH
20120809-SH
20190809-SH
20120910-SH-1
20121213-sh
20130123-SH
20130227-SH
20120417-SH
20130511-SH
20130517-SH
20130609-SH
20130701-SH
20130812-SH
20131024-SH

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95382
Status: Active
Manufacturer: Zyno Medical LLC
Manufactured In: United States
Units Affected: 34,994 units (1819 units still need correction)
Distributed To: Nationwide
Agency Last Updated: April 15, 2025

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.