FDAFDA · Food and drugs·Recall number Z-1142-2026
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
Published January 28, 2026 · Recall initiated: October 24, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Edan Diagnostics
- Distributor
- 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.
- Lot
- 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 302050-M16802330014 302089-M16802340009 302050-M16B08880011 302050-M16B08880010 302050-M16B08880009 302050-M16B08880008 302050-M16B08880007 302050-M16B08880006 302050-M16B08880005 302050-M16B08880004 302050-M16B08880003 302050-M16B08880002 302050-M16B08880001 302050-M16B08880012 302050-M16B08880013 302050-M16B11070002 302050-M16B11070005 302050-M16B11070004 302050-M16B11070003 302050-M16B11070001 302050-M16C02360005 302050-M16C02360004 302050-M16C02360003 302050-M16C02360001 302050-M16C02360002 302050-M16B08890012 302050-M16B08890011 302050-M16B08890008 302050-M16B08890009 302050-M16B08890010 302050-M16B08890001 302050-M16B08890002 302050-M16B08890003 302050-M16B08890004 302050-M16B08890005 302050-M16B08890006 302050-M16B08890007 302089-M17100570003 302089-M17100570002 302089-M17100570004 302089-M17100570005 302089-M17100570001 302122-M17202660003 302122-M17202660005 302122-M17202660002 302050-M17202650003 302122-M17202660004 302050-M17202650004 302050-M17202650002 302050-M17202650001 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-M1720187000
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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