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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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Low RiskFDA Device
Medical Devices

Zyno Medical Z-800WF Infusion Pumps Recalled for Software Incompatibility

Agency Publication Date: November 22, 2024
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Summary

Zyno Medical LLC has recalled 100 Z-800WF Infusion Pumps because the WiFi software is not compatible with the pump's main software following a recent update. These pumps are used by healthcare professionals to deliver fluids, blood, and blood products to patients through an intravenous (IV) line. No injuries or incidents have been reported in connection with this software issue.

Risk

The software mismatch may cause errors or failures in the device's WiFi communication capabilities. This recall is classified as Class III, meaning the use of these devices is not likely to cause adverse health consequences, but the software must be corrected to ensure the pump operates as intended.

What You Should Do

  1. This recall affects Zyno Medical Z-800WF Infusion Pumps, which are intended for use under the supervision of healthcare professionals.
  2. Identify affected devices by checking for model number Z-800WF and UDI-DI 00814371020006 on the device label.
  3. Verify the serial number on the device. See the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled device and contact Zyno Medical LLC or your distributor to arrange for a software correction or device return.
  5. For additional questions or to report issues, call the FDA 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-800WF Infusion Pump (Z-800 Infusion System)
Model / REF:
Z-800WF
Serial Numbers (100):
500346
500347
500348
500349
500350
500351
500352
500353
500354
500355
500356
500357
500358
500359
500360
500361
500362
500363
500364
500365
500367
500368
500369
500370
500371
500373
500374
500375
500376
500377
500378
500384
500385
500386
500388
500389
500390
500391
500392
500393
500394
502634
503435
503716
503799
503917
503921
504534
504807
504808
UDI:
00814371020006

Quantity: 100 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95635
Status: Active
Manufacturer: Zyno Medical LLC
Sold By: Zyno Medical LLC
Manufactured In: United States
Units Affected: 100 units
Distributed To: Alabama, Florida, Louisiana, Michigan, Nebraska, New Jersey, Ohio, Texas

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.