Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor
- Recalling company
- Edan Diagnostics
- Product
- Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. Component: No
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 24, 2025
- Reported
- Jan 28, 2026
- Distribution
- 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.
- Status
- Ongoing
- Quantity
- 3824
- Lot / codes
- EDAN Model: X8 UDI-DI code: 06944413810907 Serial/Lot Numbers: 261586-M21116620010 261586-M21116620002 261586-M21116620007 261586-M21116620006 261586-M21116620009 261586-M21116630001 261586-M21116620008 261586-M21116620003 261586-M21116630005 261586-M21116630003 261586-M21116620004 261586-M21116620001 261586-M21116630004 261586-M21116630002 261586-M21116620005 261586-M21301970003 261586-M21301970004 261586-M21301960001 261586-M21301970005 261586-M21301960003 261586-M21301970002 261586-M21301970001 261586-M21301960002 261586-M21714500002 261586-M21714500001 261586-M21714500003 261586-M21816750005 261586-M21816750003 261586-M21816750002 261586-M21816750004 261586-M21816750001 261586-M22105750001 261586-M22105750007 261586-M22105750008 261586-M22105750010 261586-M22105750002 261586-M22105750005 261586-M22105750009 261586-M22105750006 261586-M22105750003 261586-M22105750004 261586-M22405430007 261586-M22405430001 261586-M22405430004 261586-M22405430010 261586-M22405430006 261586-M22405430009 261586-M22405430008 261586-M22405430003 261586-M22405430002 261586-M22405430005 261586-M22615270004 261586-M22615270005 261586-M22615270001 261586-M22615270002 261586-M22615270003 261586-M23226950003 261586-M23226950002 261586-M23226950004 261586-M23226950005 261586-M23226950001 261586-M23B18320003 261586-M23B18320004 261586-M23B18330001 261586-M23B18330002 261586-M23B18330003 261586-M23B18330004 261586-M23B18320001 261586-M23B18320005 261586-M23B18330005 261586-M23B18320002 261586-M23C159100
- Company location
- San Diego, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1148-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1148-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.