Human Design Medical Vivo 65 Ventilator Recall: Unreleased Firmware Upgrade Risk

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Contact the company & request your remedy

Recalling firmHuman Design Medical Llc119 Braintree St Ste 703, N/A · Boston, MA 02134-1642

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Human Design Medical is recalling some Vivo 65 continuous ventilators due to an unreleased firmware upgrade tool. This could create risks during use, so affected users should stop using the device until a fix is available.

Why it’s dangerous

The unreleased firmware upgrade tool could cause issues with the ventilator's operation. Without a proper update, the device might not function correctly, potentially leading to unsafe breathing support.

Who’s affected

Individuals who own or use the Vivo 65 continuous ventilator for home medical care are affected. People relying on this device for breathing support are most at risk.

How to tell if you have this one

Check for the Vivo 65 continuous ventilator model with Cat. No. 204000. This device is intended for home use to provide continuous or intermittent ventilatory support.

Brand
Human Design Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using It Now
Immediately stop using the Vivo 65 ventilator until a fix is provided.

✎ GovInfoNow

Questions people ask

Why is this ventilator being recalled?

The recall is due to an unreleased firmware upgrade tool that could cause issues with the ventilator's operation.

What should I do if I have this ventilator?

Stop using the Vivo 65 ventilator immediately until a fix is provided.

Is there a specific model number for this recall?

Yes, the product is identified as Cat. No. 204000 for home use.

Take action

Contact Human Design Medical

We’ve drafted a message you can send Human Design Medical to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2530-2018 — Human Design Medical Human Design Medical

Hello,

I own a Human Design Medical that is covered by recall Z-2530-2018 from Human Design 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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Where this comes from

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.

Official source: FDA Recall #Z-2530-2018 (May 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2530-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Human Design Medical Llc recalls Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent

Recall notice