Zyno Medical recalls Z-800 Infusion Systems with unverified software versions that could lead to improper patient fluid administration. Affected units include specific serial numbers and lot codes.
Unreleased software versions were installed on distributed devices without verification or validation.
Zyno Medical is recalling its Z-800 Infusion System due to unverified software versions that may cause improper patient fluid administration. This could lead to incorrect dosing or treatment risks if the device is used without proper software validation.
The device may have unverified software versions installed without proper validation, which could lead to incorrect fluid administration or treatment errors. This poses a risk of improper patient dosing if the software is not correctly verified before use.
Patients using the Z-800 Infusion System for intravenous treatments are at risk if the device has unverified software versions. Healthcare providers and patients with specific serial numbers listed in the recall are most affected.
Check for the model number Z800 and specific serial numbers listed in the recall (e.g., 800242, 801925, 802867, etc.). The lot code and UDI-DI number 00814377102006 are also part of the affected units.
Look for the serial number on the device label to confirm if it matches the list of affected serial numbers provided in the recall.
Reach out to Zyno Medical directly for further assistance or to confirm if your device is affected.
The Z-800 Infusion System was recalled because unverified software versions were installed without proper validation, which could lead to incorrect patient fluid administration.
The recall includes specific serial numbers listed in the record, such as 800242, 801925, 802867, and others.
Check the device's serial number against the list of affected serial numbers provided in the recall notice.
We’ve drafted a message you can send Zyno Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1865-2025 — Zyno Medical Zyno Medical Hello, I own a Zyno Medical that is covered by recall Z-1865-2025 from Zyno Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
