Zyno Medical recalls Z-800WF Infusion Systems with unverified software versions that could pose safety risks. Affected units include specific model numbers and serials.
Unreleased software versions were installed on distributed devices without verification or validation.
Zyno Medical is recalling Z-800WF Infusion Systems due to unverified software versions that may not be properly validated. This could lead to potential safety issues during medical treatments.
Unverified software versions were installed without proper validation, which could lead to improper function of the infusion system. This might cause errors in delivering medical fluids or blood products.
Patients using Zyno Medical's Z-800WF Infusion Systems with specific model numbers and serials are affected. Healthcare providers administering these systems are most at risk.
Check for model number Z800WF and serial numbers listed: 500004, 500005, 500006, 500810, 500812, 500813, 501748, 503680, 503681, 503682.
Verify your Z-800WF Infusion System's model number and serial number against the listed numbers.
Unverified software versions were installed without proper validation, which could lead to improper function of the infusion system.
Model number Z800WF with serial numbers 500004, 500005, 500006, 500810, 500812, 500813, 501748, 503680, 503681, 503682.
The recall record does not specify a remedy, so check with Zyno Medical for further instructions.
We’ve drafted a message you can send Zyno Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1868-2025 — Zyno Medical Zyno Medical Hello, I own a Zyno Medical that is covered by recall Z-1868-2025 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.
