Zyno Medical recalls Z-800 Infusion Systems with specific software versions due to a defect in the air-in-line software algorithm. Affected units may require software updates or replacement.
There is a defect in the air-in-line software algorithm.
Zyno Medical is recalling certain Z-800 Infusion Systems that have a software defect in the air-in-line algorithm. This could lead to improper medication delivery if the system malfunctions. Affected users should check their product details and contact Zyno Medical for guidance.
The air-in-line software algorithm defect may cause the infusion system to deliver medication incorrectly. This could result in improper dosing or treatment interruptions if the system malfunctions during use.
Users of Zyno Medical's Z-800 Infusion Systems with specific model numbers and software versions listed in the recall are affected. Patients receiving medical treatments through these systems are at risk if the software defect causes improper medication delivery.
Check for model numbers Z-800, Z-800F, Z-800W, or Z-800WF with specific software versions listed in the recall. Also, verify the lot numbers and UDI-DI codes provided in the notice.
Review your Z-800 Infusion System's model number, software version, and lot numbers to confirm if it's affected by this recall.
Check your model number, software version, and lot numbers against the list provided in the recall notice to determine if it's affected.
Contact Zyno Medical directly for instructions on how to update the software or replace the affected unit.
The recall states there is a defect in the air-in-line software algorithm, which could lead to improper medication delivery. However, the specific risk level is not detailed in the 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-0005-2025 — Zyno Medical Zyno Medical Hello, I own a Zyno Medical that is covered by recall Z-0005-2025 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.