Edan Fetal & Maternal Monitor Recall: Cybersecurity Risk

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Edan is recalling several fetal and maternal monitors (F6, F9, F6 Express, F9 Express) because of potential cybersecurity issues. This could allow unauthorized access to the device's data. Affected units have specific serial numbers listed in the recall notice.

Why it’s dangerous

The recall is due to potential cybersecurity vulnerabilities that could allow unauthorized access to the device's data. This is a data privacy concern, not a physical hazard like fire or injury.

Who’s affected

Pregnant women and their healthcare providers who own or use the recalled fetal and maternal monitors. The risk is primarily related to potential unauthorized data access, not physical harm.

How to tell if you have this one

Check if your monitor has a serial number starting with 460430, 460956, 560039, or 560156 (the specific numbers listed in the recall notice). The models affected are F6, F9, F6 Express, and F9 Express.

Brand
Edan
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Your Monitor's Serial Number
Look for the serial number on your monitor's label, which starts with 460430, 460956, 560039, or 560156.
Contact Edan for Details
If your monitor is listed in the recall, contact Edan Diagnostics directly for further instructions.

✎ GovInfoNow

Questions people ask

Why is my monitor being recalled?

Edan is recalling these monitors due to potential cybersecurity issues that could allow unauthorized access to the device's data.

Is there a risk of injury from this recall?

No, this recall is for cybersecurity concerns only and does not involve physical hazards like injury or fire.

How do I check if my monitor is affected?

Check your monitor's serial number, which starts with 460430, 460956, 560039, or 560156 as listed in the recall notice.

Take action

Contact Edan

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

✉️ Open in email

Subject: Recall Z-1141-2026 — Edan Edan

Hello,

I own a Edan that is covered by recall Z-1141-2026 from Edan.

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-1141-2026 (October 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1141-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product

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