Recall archive / FDA device enforcement
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Moni... — FDA record Z-1142-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 24, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. 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
- Recalling firm
- Edan Diagnostics
- Quantity
- 13934
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1142-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | EDAN Model: M3 UDI-DI code: 06944413800618 Serial/Lot Number: 302050-M16200560001 302050-M16200560002 302089-M16203830017 302089-M16203830006 302089-M16203830020 302127-M15B11010006 302127-M16203840001 302127-M16203840002 302127-M16203840003 302127-M16203840004 302127-M16203840005 302127-M16203840006 302127-M16203840007 302127-M16203840008 302127-M16203840009 302127-M16203840010 302127-M16203840011 302127-M16203840012 302127-M16203840013 302127-M16203840014 302089-M16203830019 302089-M16203830018 302089-M16203830016 302089-M16203830015 302089-M16203830014 302089-M16203830013 302089-M16203830012 302089-M16203830011 302089-M16203830010 302089-M16203830008 302089-M16203830007 302089-M16203830005 302089-M16203830004 302089-M16203830009 302050-M16203850007 302089-M16203830003 302050-M16203850001 302089-M16203830002 302089-M16203830001 302050-M16203850010 302050-M16203850009 302050-M16203850008 302050-M16203850002 302050-M16203850006 302050-M16203850005 302050-M16203850004 302050-M16203850003 302050-M16407160008 302050-M16407160007 302050-M16407160006 302050-M16407160005 302050-M16407160004 302050-M16407160003 302050-M16407160002 302050-M16407160001 302050-M16407160009 302050-M16407160010 302127-M16407150005 302127-M16407150004 302127-M16407150003 302127-M16407150002 302127-M16407150001 302089-M16407140001 302089-M16407140002 302089-M16407140004 302089-M16407140005 302089-M16407140006 302089-M16407140007 302089-M16407140008 302089-M16407140009 302089-M16407140010 302089-M16407140003 302050-M16802330001 302050-M16802330002 302050-M16802330003 302089-M16802340010 302050-M16802330004 302050-M16802330005 302050-M16802330006 302050-M16802330007 302050-M16802330008 302050-M16802330009 302050-M16802330010 302050-M16802330011 302050-M16802330012 302050-M16802330013 302050-M16802330015 302089-M16802340001 302089-M16802340002 302089-M16802340003 302089-M16802340004 302089-M16802340005 302089-M16802340006 302089-M16802340007 302089-M16802340008 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302122-M17202660001 302050-M17202650005 302089-M17201870019 302089-M17201870018 302089-M17201870017 302089-M17201870013 302089-M17201870012 302089-M17201870011 302050-M17201860018 302050-M17201860016 302050-M17201860010 302050-M17201860006 302050-M17201860003 302050-M17201860004 302050-M17201860013 302050-M17201860014 302089-M17201870022 302089-M17201870005 302089-M17201870004 302089-M17201870021 302089-M17201870006 302050-M17201860021 302050-M17201860015 302050-M17201860024 302050-M17201860011 302050-M17201860009 302050-M17201860025 302089-M17201870020 302089-M17201870001 302089-M17201870015 302050-M17201860022 302050-M17201860020 302050-M17201860019 302050-M17201860017 302050-M17201860007 302050-M17201860005 302089-M17201870014 302089-M17201870002 302089-M17201870003 302089-M17201870007 302050-M17201860023 302050-M17201860008 302050-M17201860012 302050-M17201860002 302050-M17201860001 302089-M17201870025 302089-M17201870024 302089-M17201870023 302089-M17201870016 302089-M17201870010 302089-M17201870009 302089-M17201870008 302050-M17302660001 302050-M17302660010 302050-M17302660004 302050-M17302660012 302089-M17302670001 302089-M17302670007 302089-M17302670008 302050-M17302660011 302089-M17302670009 302050-M17302660008 302050-M17302660014 302050-M17302660003 302089-M17302670002 302050-M17302660009 302050-M17302660013 302089-M17302670003 302089-M17302670004 302089-M17302670005 302089-M17302670010 302050-M17302660002 302089-M17302670006 302050-M17302660015 302050-M17302660007 302050-M17302660006 302050-M17302660005 302050-M17305620001 302050-M17305620003 302050-M17305620013 302089-M17305630005 302089-M17305630012 302089-M17305630003 302050-M17305620006 302089-M17305630002 302127-M17305610001 302050-M17305620007 302089-M17305630004 302089-M17305630008 302127-M17305610003 302127-M17305610004 302089-M17305630013 302050-M17305620011 302127-M17305610007 302127-M17305610005 302089-M17305630014 302127-M17305610009 302089-M17305630001 302127-M17305610010 302127-M17305610008 302127-M17305610002 302089-M17305630015 302089-M17305630009 302089-M17305630006 302050-M17305620009 302089-M17305630011 302089-M17305630007 302050-M17305620012 302050-M17305620010 302050-M17305620008 302050-M17305620002 302050-M17305620004 302089-M17305630010 302050-M17305620015 302050-M17305620014 302050-M17305620005 302127-M17305610006 302089-M17604420007 302089-M17604420015 302089-M17604420003 302089-M17604420009 302089-M17604420005 302050-M17604410014 302050-M17604410006 302089-M17604420002 302050-M17604410004 302050-M17604410009 302089-M17604420012 302050-M17604410001 302050-M17604410002 302050-M17604410007 302050-M17604410008 302089-M17604420010 302089-M17604420014 302089-M17604420011 302050-M17604410005 302050-M17604410003 302050-M17604410015 302050-M17604410013 302089-M17604420006 302050-M17604410010 302050-M17604410011 302050-M17604410012 302089-M17604420001 302089-M17604420004 302089-M17604420008 302089-M17604420013 001676-M17812850002 001676-M17812850003 001676-M17812850004 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360124-M18307580015 360124-M18307590006 360124-M18307590008 360124-M18307590009 360124-M18307590011 360124-M18307580014 360124-M18307600001 360124-M18307580006 360124-M18307600002 360124-M18307600003 360124-M18307580010 360124-M18307590001 360124-M18307590014 360124-M18307590015 360124-M18307580011 360124-M18307580004 360124-M18307590007 360124-M18307580001 360124-M18307590003 360124-M18307580002 360124-M18307600005 360124-M18307580008 360124-M18307590002 360124-M18307590020 360124-M18307590017 360124-M18307590010 360124-M18307580013 360124-M18401450010 360124-M18401450008 360124-M18401450005 360124-M18401450006 360124-M18401450004 360124-M18401450003 360124-M18401450001 360124-M18401450002 360124-M18401450009 360124-M18401450007 360124-M18407600005 360124-M18407600004 360124-M18407600006 360124-M18407600009 360124-M18407600014 360124-M18407600013 360124-M18407600002 360124-M18407600011 360124-M18407610004 360124-M18407600007 360124-M18407600008 360124-M18407600010 360124-M18407610003 360124-M18407600001 360124-M18407600012 360124-M18407600003 360124-M18407610002 360124-M18407610001 360124-M18407600015 360124-M18407610005 360124-M18508710001 360124-M18508710003 360124-M18508720004 360124-M18508700004 360124-M18508720005 360124-M18508710004 360124-M18508700009 360124-M18508700008 360124-M18508720001 360124-M18508710005 360124-M18508700003 360124-M18508700010 360124-M18508700005 360124-M18508700007 360124-M18508710002 360124-M18508720002 360124-M18508720003 360124-M18508700001 360124-M18508700002 360124-M18508700006 360124-M18613460009 360124-M18613480007 360124-M18613480002 360124-M18613480003 360124-M18613470003 360124-M18613460003 360124-M18613480005 360124-M18613460007 360124-M18613460008 360124-M18613460004 360124-M18613460002 360124-M18613460001 360124-M18613480001 360124-M18613470004 360124-M18613470002 360124-M18613460006 360124-M18613480010 360124-M18613470005 360124-M18613480006 360124-M18613480004 360124-M18613470001 360124-M18613460010 360124-M18613480008 360124-M18613460005 360124-M18613480009 360124-M18800850005 360124-M18800830010 360124-M18800830013 360124-M18800840004 360124-M18800840005 360124-M18800830014 360124-M18800830015 360124-M18800850001 360124-M18800850006 360124-M18800850009 360124-M18800850010 360124-M18800830009 360124-M18800830007 360124-M18800830011 360124-M18800830008 360124-M18800830004 360124-M18800850007 360124-M18800830003 360124-M18800830006 360124-M18800830002 360124-M18800830001 360124-M18800850008 360124-M18800840003 360124-M18800850002 360124-M18800830005 360124-M18800840002 360124-M18800840001 360124-M18800830012 360124-M18800850004 360124-M18800850003 360124-M18901440014 360124-M18901440007 360124-M18901440001 360124-M18901440004 360124-M18901440013 360124-M18901430002 360124-M18901430003 360124-M18901440005 360124-M18901440011 360124-M18901430004 360124-M18901440012 360124-M18901440003 360124-M18901440009 360124-M18901430005 360124-M18901430007 360124-M18901430009 360124-M18901430001 360124-M18901440002 360124-M18901440015 360124-M18901440010 360124-M18901440006 360124-M18901430010 360124-M18901440008 360124-M18901430006 360124-M18901430008 360124-M18A10610007 360124-M18A10610008 360124-M18A10600002 360124-M18A10600004 360124-M18A10600006 360124-M18A10620001 360124-M18A10610009 360124-M18A10600003 360124-M18A10600007 360124-M18A10610005 360124-M18A10610004 360124-M18A10610002 360124-M18A10610003 360124-M18A10600009 360124-M18A10610001 360124-M18A10620005 360124-M18A10620004 360124-M18A10620002 360124-M18A10610010 360124-M18A10600001 360124-M18A10600008 360124-M18A10610006 360124-M18A10600010 360124-M18A10600005 360124-M18A10620003 360124-M18C07400017 360124-M18C07400011 360124-M18C07400013 360124-M18C07390028 360124-M18C07390027 360124-M18C07390026 360124-M18C07390018 360124-M18C07390017 360124-M18C07390016 360124-M18C07390003 360124-M18C07400003 360124-M18C07400010 360124-M18C07400001 360124-M18C07380005 360124-M18C07400019 360124-M18C07400009 360124-M18C07400016 360124-M18C07400006 360124-M18C07390009 360124-M18C0740... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 28, 2026
- Recall initiation date
- Oct 24, 2025
- Center classification date
- Jan 22, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.