Edan Diagnostics — GovInfoNow

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Contact the company & request your remedy

Recalling firmEdan Diagnostics9833 Pacific Heights Blvd · San Diego, CA 92121-4707

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

Edan Diagnostics

Why it’s dangerous

This is a low risk product

Who’s affected

All

How to tell if you have this one

Edan Diagnostics

Brand
Edan Diagnostics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

1
Check the product for any signs of damage or defects.
2
Ensure the product is used according to the manufacturer's instructions.
3
Contact Edan Diagnostics customer support for further assistance.

✎ GovInfoNow

Questions people ask

What is Edan Diagnostics?

Edan Diagnostics is a company that provides diagnostic products and services.

How do I contact Edan Diagnostics for support?

You can contact Edan Diagnostics customer support through their website or by phone.

Take action

Contact Edan Diagnostics

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

✉️ Open in email

Subject: Recall Z-1154-2026 — Edan Diagnostics Edan Diagnostics

Hello,

I own a Edan Diagnostics that is covered by recall Z-1154-2026 from Edan Diagnostics.

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-1154-2026 (October 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1154-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.

Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series

Lower-risk recall