Zyno Medical LLC recalls
9 recalls in our records from 2013 to 2025: 9 FDA medical devices.
Recalls with full detail pages
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Zyno Medical LLC medical device recall: Z-800 Infusion System. Intended to provide intravenous infusion of…
Unreleased software versions were installed on distributed devices without verification or validation.
Earlier and other recalls
These link to the official agency notice.
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Zyno Medical LLC medical device recall: Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog… Official notice ↗
For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.
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Zyno Medical LLC medical device recall: Z-800 Infusion System. Model/Catalog Number: Z-800 Official notice ↗
Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
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Zyno Medical LLC medical device recall: Z-800 Infusion System Official notice ↗
There is a defect in the air-in-line software algorithm.
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Zyno Medical LLC medical device recall: Zyno Medical Z800 Official notice ↗
Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery…
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Zyno Medical LLC medical device recall: Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide… Official notice ↗
When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume…
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Zyno Medical LLC medical device recall: Zyno Medical Administration Set -105"ADMIN SET 20DP Official notice ↗
Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when…
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Zyno Medical LLC medical device recall: Zyno Medical Administration Set Official notice ↗
Administration Set potential filter leaking
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Zyno Medical LLC medical device recall: Z-800 Volumetric Infusion System. For intravenous infusion of… Official notice ↗
Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.