Edan recalls M3B Vital Signs Monitors due to potential cybersecurity issues. Affected units have serial numbers listed in the recall notice. Consumers should contact Edan for details.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan is recalling its M3B Vital Signs Monitors because of potential cybersecurity issues. This could allow unauthorized access to patient health data in hospital settings. The recall affects specific models with serial numbers listed in the notice.
The device has cybersecurity vulnerabilities that could allow unauthorized access to patient health data. This risk is specific to hospital environments where the monitor is used for continuous vital signs monitoring.
Healthcare facilities using the M3B Vital Signs Monitor are most at risk. Consumers with the affected model numbers should check if their device is included.
Check for the M3B model with serial numbers listed in the recall notice. The serial numbers start with 261184, 302135, or 360126 followed by specific codes.
Look for the serial number on your M3B Vital Signs Monitor, which starts with 261184, 302135, or 360126 followed by specific codes.
Reach out to Edan Diagnostics to confirm if your device is affected and get instructions on next steps.
Check your device's serial number against the list provided in the recall notice to see if it's affected.
Contact Edan Diagnostics to get instructions on next steps for affected devices.
Look for the serial number on your device, which starts with 261184, 302135, or 360126 followed by specific codes listed in the recall notice.
We’ve drafted a message you can send Edan to request your refund or repair — edit it as you like.
Subject: Recall Z-1152-2026 — Edan Edan Hello, I own a Edan that is covered by recall Z-1152-2026 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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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.
