Reported Jan 28, 2026 · Ongoing
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12…
Edan Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edan Diagnostics · 9833 Pacific Heights Blvd · San Diego, CA · 92121-4707
Is this the product you have?
- Brand NameEDAN
- Product NamePatient
- Monitor Model/Catalog Number
X8X10
- X12 Product DescriptionThe 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
- ComponentNo
- Lot codes and dates
- EDAN ModelX8
- UDI-DI code06944413810907
- Serial/Lot Numbers
598 of 598 codes
261586-M21116620010261586-M21116620002261586-M21116620007261586-M21116620006261586-M21116620009261586-M21116630001261586-M21116620008261586-M21116620003261586-M21116630005261586-M21116630003261586-M21116620004261586-M21116620001261586-M21116630004261586-M21116630002261586-M21116620005261586-M21301970003261586-M21301970004261586-M21301960001261586-M21301970005261586-M21301960003261586-M21301970002261586-M21301970001261586-M21301960002261586-M21714500002261586-M21714500001261586-M21714500003261586-M21816750005261586-M21816750003261586-M21816750002261586-M21816750004261586-M21816750001261586-M22105750001261586-M22105750007261586-M22105750008261586-M22105750010261586-M22105750002261586-M22105750005261586-M22105750009261586-M22105750006261586-M22105750003261586-M22105750004261586-M22405430007261586-M22405430001261586-M22405430004261586-M22405430010261586-M22405430006261586-M22405430009261586-M22405430008261586-M22405430003261586-M22405430002261586-M22405430005261586-M22615270004261586-M22615270005261586-M22615270001261586-M22615270002261586-M22615270003261586-M23226950003261586-M23226950002261586-M23226950004261586-M23226950005
- EDAN ModelX10
- UDI-DI code06944413810921
- Serial/Lot Numbers
1,026 of 1,026 codes
261590-M21116650004261590-M21116640010261590-M21116650001261590-M21116640009261590-M21116640002261590-M21116640001261590-M21116640008261590-M21116640006261590-M21116650003261590-M21116640004261590-M21116650005261590-M21116640007261590-M21116640003261590-M21116640005261590-M21116650002261590-M21301930004261590-M21301930003261590-M21301930002261590-M21301940001261590-M21301940003261590-M21301930005261590-M21301930001261590-M21301940002261590-M21608900002261590-M21608900001261590-M21608900003261590-M21608900004261590-M21714510002261590-M21714510005261590-M21714510001261590-M21714510003261590-M21714510004261590-M21816760004261590-M21816760003261590-M21816760005261590-M21816760002261590-M21816760001261590-M21C04540001261590-M21C04540005261590-M21C04540009261590-M21C04540003261590-M21C04540004261590-M21C04540007261590-M21C04540015261590-M21C04540006261590-M21C04540010261590-M21C04540013261590-M21C04540014261590-M21C04540008261590-M21C04540012261590-M21C04540011261590-M21C04540002261590-M22105760002261590-M22105760001261590-M22105760005261590-M22105760004261590-M22105760003261590-M22209740001261590-M22209740004261590-M22209750005
- Amount recalled
- 3824
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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