Recall archive / FDA device enforcement
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three w... — FDA record Z-1143-2026
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: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. 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
- 11987
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1143-2026
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: iM3 UDI-DI code: 06944413808812 Serial/Lot Numbers: 261436-M19B06650005 261436-M19B06650003 261436-M19B06660007 261436-M19B06650002 261436-M19B06660001 261436-M19B06660004 261436-M19B06650001 261436-M19B06660008 261436-M19B06660003 261436-M19B06660002 261436-M19B06660006 261436-M19B06650004 261436-M19B06660010 261436-M19B06660005 261436-M19B06660009 261436-M19C16980011 261436-M19C16980013 261436-M19C16980002 261436-M19C16980004 261436-M19C16980006 261436-M19C16980012 261436-M19C16980009 261436-M19C16980010 261436-M19C16980015 261436-M19C16980003 261436-M19C16980005 261436-M19C16980008 261436-M19C16980001 261436-M19C16980007 261436-M19C16980014 261436-M20707940016 261436-M20707940014 261436-M20707940008 261436-M20707940002 261436-M20707940020 261436-M20707940006 261436-M20707940004 261436-M20707940001 261436-M20707940012 261436-M20707940018 261436-M20707940009 261436-M20707940010 261436-M20707940011 261436-M20707940003 261436-M20707940005 261436-M20707940013 261436-M20707940007 261436-M20707940015 261436-M20707940017 261436-M20707940019 261436-M20808640010 261436-M20808640006 261436-M20808640008 261436-M20808640003 261436-M20808640005 261436-M20808640009 261436-M20808640001 261436-M20808640002 261436-M20808640007 261436-M20808640004 261436-M20914760002 261436-M20914760025 261436-M20914760015 261436-M20914760024 261436-M20914760023 261436-M20914760020 261436-M20914760016 261436-M20914760014 261436-M20914760013 261436-M20914760001 261436-M20914760012 261436-M20914760011 261436-M20914760010 261436-M20914760007 261436-M20914760018 261436-M20914760017 261436-M20914760008 261436-M20914760006 261436-M20914760004 261436-M20914760003 261436-M20914760009 261436-M20914760005 261436-M20914760022 261436-M20914760021 261436-M20914760019 261478-M18208600001 261436-M20B13260015 261436-M20B13260048 261436-M20B13260044 261436-M20B13260035 261436-M20B13260049 261436-M20B13260046 261436-M20B13260042 261436-M20B13260028 261436-M20B13260025 261436-M20B13260022 261436-M20B13260012 261436-M20B13260029 261436-M20B13260043 261436-M20B13260047 261436-M20B13260005 261436-M20B13260016 261436-M20B13260017 261436-M20B13260019 261436-M20B13260031 261436-M20B13260033 261436-M20B13260024 261436-M20B13260026 261436-M20B13260001 261436-M20B13260018 261436-M20B13260040 261436-M20B13260007 261436-M20B13260011 261436-M20B13260013 261436-M20B13260030 261436-M20B13260002 261436-M20B13260006 261436-M20B13260009 261436-M20B13260010 261436-M20B13260045 261436-M20B13260050 261436-M20B13260004 261436-M20B13260008 261436-M20B13260014 261436-M20B13260020 261436-M20B13260021 261436-M20B13260032 261436-M20B13260036 261436-M20B13260037 261436-M20B13260039 261436-M20B13260023 261436-M20B13260027 261436-M20B13260034 261436-M20B13260038 261436-M20B13260041 261436-M20B13260003 261436-M20B15440003 261436-M20C15770021 261436-M20C15770016 261436-M20C15770008 261436-M20C15770007 261436-M20B20350081 261436-M20B20350077 261436-M20B20350068 261436-M20B20350058 261436-M20B20350052 261436-M20B20350046 261436-M20B20350041 261436-M20B20350037 261436-M20B20350033 261436-M20B20350030 261436-M20B20350028 261436-M20B20350022 261436-M20B20350006 261436-M20C13740012 261436-M20C13740010 261436-M20C13740002 261436-M20B15440004 261436-M20B15440005 261436-M20B15440016 261436-M20B15440020 261436-M20B15440018 261436-M20B15440010 261436-M20B15440006 261436-M20C15770025 261436-M20C15770019 261436-M20C15770001 261436-M20B20350084 261436-M20B20350061 261436-M20B20350056 261436-M20B20350051 261436-M20B15440021 261436-M20B20350048 261436-M20B20350036 261436-M20B20350029 261436-M20B20350008 261436-M20B20350002 261436-M20C13740009 261436-M20C13740004 261436-M20C13740011 261436-M20C13740008 261436-M20C13740001 261436-M20B20350042 261436-M20B15440017 261436-M20B15440009 261436-M20B15440008 261436-M20B15440019 261436-M20C15770023 261436-M20C15770018 261436-M20C15770017 261436-M20C15770010 261436-M20C15770006 261436-M20B20350089 261436-M20B20350067 261436-M20B20350063 261436-M20B20350060 261436-M20B20350053 261436-M20B20350050 261436-M20B20350040 261436-M20B20350038 261436-M20B20350024 261436-M20C13740019 261436-M20C13740014 261436-M20C13740005 261436-M20B20350043 261436-M20B15440022 261436-M20B20350014 261436-M20B20350015 261436-M20C15770002 261436-M20B20350091 261436-M20B20350085 261436-M20B20350076 261436-M20B20350071 261436-M20B20350059 261436-M20B20350047 261436-M20B20350039 261436-M20B20350035 261436-M20B20350026 261436-M20B20350018 261436-M20B20350012 261436-M20B20350007 261436-M20B20350003 261436-M20C13740013 261436-M20C13740003 261436-M20B20350004 261436-M20B20350095 261436-M20B20350087 261436-M20B20350083 261436-M20B20350080 261436-M20B20350079 261436-M20B20350075 261436-M20B20350066 261436-M20B20350054 261436-M20C15770020 261436-M20B15440002 261436-M20B15440014 261436-M20C13740016 261436-M20B15440015 261436-M20B15440013 261436-M20B15440001 261436-M20C15770024 261436-M20C15770015 261436-M20C15770013 261436-M20B20350045 261436-M20C15770004 261436-M20B20350090 261436-M20B20350086 261436-M20B20350073 261436-M20B20350070 261436-M20B20350062 261436-M20B20350034 261436-M20B20350025 261436-M20B20350017 261436-M20B20350013 261436-M20B20350010 261436-M20B20350001 261436-M20C13740020 261436-M20B20350093 261436-M20B20350031 261436-M20C15770012 261436-M20B20350020 261436-M20B20350092 261436-M20B20350078 261436-M20B20350072 261436-M20B20350064 261436-M20B20350057 261436-M20B20350049 261436-M20B20350032 261436-M20B20350023 261436-M20B20350011 261436-M20B20350009 261436-M20C13740017 261436-M20C13740015 261436-M20C15770003 261436-M20C13740007 261436-M20C15770011 261436-M20C15770009 261436-M20B20350094 261436-M20B20350088 261436-M20B20350082 261436-M20B20350074 261436-M20B20350069 261436-M20B20350065 261436-M20B20350055 261436-M20B20350044 261436-M20B20350021 261436-M20B20350019 261436-M20B15440011 261436-M20C15770005 261436-M20B20350027 261436-M20B15440024 261436-M20C15770022 261436-M20B20350005 261436-M20C15770014 261436-M20C13740018 261436-M20B15440023 261436-M20B15440012 261436-M20B15440007 261436-M20B15440025 261436-M20C13740006 261436-M20B20350016 261436-M21108500009 261436-M21108510002 261436-M21108510001 261436-M21108500003 261436-M21108510015 261436-M21108510014 261436-M21108510013 261436-M21108510003 261436-M21108510004 261436-M21108510006 261436-M21108500002 261436-M21108500001 261436-M21108510005 261436-M21108510012 261436-M21108510011 261436-M21108510018 261436-M21108510020 261436-M21108500005 261436-M21108510010 261436-M21108510019 261436-M21108500006 261436-M21108500007 261436-M21108500004 261436-M21108500008 261436-M21108500010 261436-M21108510007 261436-M21108510008 261436-M21108510009 261436-M21108510016 261436-M21108510017 261436-M21318130004 261436-M21318130002 261436-M21318130040 261436-M21318130039 261436-M21318130033 261436-M21318130026 261436-M21318130016 261436-M21318130012 261436-M21318130031 261436-M21318130027 261436-M21318130025 261436-M21318130020 261436-M21318130011 261436-M21318130014 261436-M21318130021 261436-M21318130023 261436-M21318130017 261436-M21318130034 261436-M21318130032 261436-M21318130029 261436-M21318130028 261436-M21318130038 261436-M21318130022 261436-M21318130006 261436-M21318130003 261436-M21318130024 261436-M21318130015 261436-M21318130010 261436-M21318130007 261436-M21318130005 261436-M21318130035 261436-M21318130030 261436-M21318130013 261436-M21318130036 261436-M21318130001 261436-M21318130037 261436-M21318130019 261436-M21318130018 261436-M21318130009 261436-M21318130008 261436-M21C04370027 261436-M21C04370003 261436-M21C04380005 261436-M21C04370028 261436-M21C04370022 261436-M21C04370021 261436-M21C04370017 261436-M21C04380009 261436-M21C04380002 261436-M21C04380001 261436-M21C04370012 261436-M21C04370005 261436-M21C04370004 261436-M21C04380010 261436-M21C04380003 261436-M21C04380004 261436-M21C04380012 261436-M21C04380013 261436-M21C04380008 261436-M21C04370030 261436-M21C04370015 261436-M21C04370013 261436-M21C04370009 261436-M21C04380015 261436-M21C04370029 261436-M21C04370026 261436-M21C04370018 261436-M21C04370011 261436-M21C04370010 261436-M21C04370007 261436-M21C04380006 261436-M21C04370020 261436-M21C04370019 261436-M21C04380011 261436-M21C04380007 261436-M21C04370025 261436-M21C04370024 261436-M21C04370023 261436-M21C04370016 261436-M21C04370008 261436-M21C04370002 261436-M21C04370001 261436-M21C04370014 261436-M21C04370006 261436-M21C04380014 261436-M22214180005 261436-M22209730004 261436-M22209730009 261436-M22214180004 261436-M22209730010 261436-M22214180001 261436-M22209730006 261436-M22209730001 261436-M22209730003 261436-M22214180002 261436-M22214180003 261436-M22209730008 261436-M22209730005 261436-M22209730007 261436-M22209730002 261436-M22405350008 261436-M22405350009 261436-M22405350010 261436-M22405350003 261436-M22405350004 261436-M22405350005 261436-M22405350006 261436-M22405350007 261436-M22405350002 261436-M22405350001 261436-M22511240001 261436-M22513180002 261436-M22513180010 261436-M22511240002 261436-M22511240003 261436-M22511240006 261436-M22511240007 261436-M22513180006 261436-M22511240004 261436-M22511240005 261436-M22513180004 261436-M22513180001 261436-M22513180005 261436-M22511240008 261436-M22513180003 261436-M22513180008 261436-M22511240010 261436-M22513180007 261436-M22513180009 261436-M22511240009 261436-M22615520007 261436-M22615520005 261436-M22615520004 261436-M22615520008 261436-M22615520009 261436-M22615520010 261436-M22615520003 261436-M22615520006 261436-M22615520002 261436-M22615520001 261436-M22800750001 261436-M22800750002 261436-M22800750004 261436-M22800750003 261436-M22800750005 261436-M22807950002 261436-M22808100019 261436-M22808100015 261436-M22808100009 261436-M22808100005 261436-M22807950009 261436-M22808100008 261436-M22808100007 261436-M22807950004 261436-M22808100003 261436-M22807950008 261436-M22807950007 261436-M22807950006 261436-M22808100014 261436-M22808100002 261436-M22808100001 261436-M22807950011 261436-M22807950005 261436-M22807950012 261436-M22807950014 261436-M22808100016 261436-M22807950001 261436-M22808100006 261436-M22807950015 261436-M22807950010 261436-M22808100011 261436-M22808100004 261436-M22807950013 261436-M22807950003 261436-M22808100020 261436-M22808100018 261436-M22808100017 261436-M22808100013 261436-M22808100010 261436-M22808100012 261436-M22905190003 261436-M22905190002 261436-M22905190005 261436-M22905190006 261436-M22905190004 261436-M22905190001 261436-M22918110002 261436-M22918110022 261436-M22918100009 261436-M22918100015 261436-M22918100016 261436-M22918100023 261436-M22918100024 261436-M22918110008 261436-M22918110019 261436-M22918110024 261436-M22918110027 261436-M22918100011 261436-M22918100031 261436-M22918100041 261436-M22918100044 261436-M22918110005 261436-M22918100043 261436-M22918100033 261436-M22918100019 261436-M22918100021 261436-M22918100039 261436-M22918100049 261436-M22918110007 261436-M22918110009 261436-M22918110014 261436-M22918110017 261436-M22918110029 261436-M22918100007 261436-M22918100008 261436-M22918100012 261436-M22918100018 261436-M22918100027 261436-M22918100028 261436-M22918100030 261436-M22918100034 261436-M22918110015 261436-M22918110023 261436-M22918110025 261436-M22918110013 261436-M22918110003 261436-M22918100022 261436-M22918100017 261436-M22918100001 261436-M22918110030 261436-M22918110012 261436-M22918110004 261436-M22918100050 261436-M22918100046 261436-M22918100045 261436-M22918100040 261436-M22918100036 261436-M22918100035 261436-M22918100002 261436-M22918110021 261436-M22918110018 261436-M22918110016 261436-M22918110010 261436-M22918110001 261436-M22918100042 261436-M22918100038 261436-M22918100032 261436-M22918100025 261436-M22918100020 261436-M22918100014 261436-M22918100010 261436-M22918100005 261436-M22918110006 261436-M22918100006 261436-M22918110028 261436-M22918110026 261436-M22918110020 261436-M22918110011 261436-M22918100048 261436-M22918100037 261436-M22918100047 261436-M22918100004 261436-M22918100013 261436-M22918100026 261436-M22918100029 261436-M22918... |
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.