Edan Diagnostics 2026-01-28 Health serious FDA
Health · FDA · Recall #FDA-Z-1142-2026
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product… Recall
Issued January 28, 2026 · Edan Diagnostics
In January 2026, Edan Diagnostics recalled the Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Edan Diagnostics to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Edan Diagnostics
- Category
- Health
- Recall date
- January 28, 2026
- Units affected
- Not reported
- Sold at
- Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
- Recall number
- FDA-Z-1142-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Edan Diagnostics has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.