Recall archive / FDA device enforcement
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Mon... — FDA record Z-1153-2026
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: M3A 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
- 12201
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1153-2026
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: M3A UDI-DI code: 06944413800786 Serial/Lot Numbers: 260760-M16406920062 260760-M16406920035 260760-M16406920036 260760-M16406920037 260760-M16406920038 260760-M16406920039 260760-M16406920040 260760-M16406920041 260760-M16406920042 260760-M16406920043 260760-M16406920044 260760-M16406920045 260760-M16406920046 260760-M16406920047 260760-M16406920048 260760-M16406920049 260760-M16406920050 260760-M16406920051 260760-M16406920052 260760-M16406920053 260760-M16406920054 260760-M16406920055 260760-M16406920056 260760-M16406920057 260760-M16406920058 260760-M16406920059 260760-M16406920060 260760-M16406920061 260760-M16406920034 260760-M16406920033 260760-M16406920001 260760-M16406920031 260760-M16406920063 260760-M16406920002 260760-M16406920003 260760-M16406920004 260760-M16406920005 260760-M16406920006 260760-M16406920007 260760-M16406920008 260760-M16406920009 260760-M16406920010 260760-M16406920011 260760-M16406920012 260760-M16406920013 260760-M16406920014 260760-M16406920015 260760-M16406920016 260760-M16406920017 260760-M16406920019 260760-M16406920020 260760-M16406920021 260760-M16406920022 260760-M16406920023 260760-M16406920024 260760-M16406920025 260760-M16406920026 260760-M16406920027 260760-M16406920028 260760-M16406920029 260760-M16406920030 260760-M16406920032 260760-M16406920064 260760-M16406920018 260760-M16406920066 260760-M16406920065 260760-M16406920070 260760-M16406920069 260760-M16406920068 260760-M16406920067 260084-M16408640030 260084-M16408640029 260084-M16408640028 260084-M16408640004 260084-M16408640026 260084-M16408640027 260084-M16408640023 260084-M16408640022 260084-M16408640021 260084-M16408640020 260084-M16408640019 260084-M16408640018 260084-M16408640017 260084-M16408640016 260084-M16408640015 260084-M16408640014 260084-M16408640012 260084-M16408640013 260084-M16408640010 260084-M16408640025 260084-M16408640024 260084-M16408640001 260084-M16408640011 260084-M16408640003 260084-M16408640002 260084-M16408640006 260084-M16408640007 260084-M16408640008 260084-M16408640009 260084-M16408640005 260760-M16604770010 260760-M16604770009 260760-M16604770008 260760-M16604770007 260760-M16604770006 260760-M16604770005 260760-M16604770002 260760-M16604770003 260760-M16604770001 260760-M16604770011 260760-M16604770004 260760-M16604770012 260760-M16604770014 260760-M16604770015 260760-M16604770016 260760-M16604770017 260760-M16604770018 260760-M16604770019 260760-M16604770020 260760-M16604770013 260760-M16604780026 260760-M16604780021 260760-M16604780022 260760-M16604780023 260760-M16604780024 260760-M16604780025 260760-M16604780027 260760-M16604780033 260760-M16604780029 260760-M16604780030 260760-M16604780031 260760-M16604780032 260760-M16604780020 260760-M16604780034 260760-M16604780035 260760-M16604780028 260760-M16604780019 260760-M16604780013 260760-M16604780017 260760-M16604780001 260760-M16604780002 260760-M16604780003 260760-M16604780004 260760-M16604780005 260760-M16604780036 260760-M16604780007 260760-M16604780008 260760-M16604780009 260760-M16604780010 260760-M16604780011 260760-M16604780012 260760-M16604780014 260760-M16604780015 260760-M16604780016 260760-M16604780018 260760-M16604780006 260760-M16604780037 260760-M16604780039 260760-M16604780063 260760-M16604780064 260760-M16604780065 260760-M16604780066 260760-M16604780067 260760-M16604780068 260760-M16604780038 260760-M16604780070 260760-M16604780061 260760-M16604780071 260760-M16604780073 260760-M16604780074 260760-M16604780075 260760-M16604780076 260760-M16604780077 260760-M16604780078 260760-M16604780079 260760-M16604780080 260760-M16604780072 260760-M16604780060 260760-M16604780069 260760-M16604780058 260760-M16604780040 260760-M16604780041 260760-M16604780042 260760-M16604780043 260760-M16604780044 260760-M16604780045 260760-M16604780059 260760-M16604780047 260760-M16604780048 260760-M16604780046 260760-M16604780050 260760-M16604780049 260760-M16604780056 260760-M16604780055 260760-M16604780054 260760-M16604780053 260760-M16604780052 260760-M16604780057 260760-M16604780062 260760-M16604780051 260760-M16807410004 260760-M16807410005 260760-M16807410006 260760-M16807410003 260760-M16807410007 260760-M16807410008 260760-M16807410009 260760-M16807410010 260760-M16807410011 260760-M16807410012 260760-M16807410013 260760-M16807410022 260760-M16807410015 260760-M16807410016 260760-M16807410017 260760-M16807410018 260760-M16807410019 260760-M16807410020 260760-M16807410021 260760-M16807410023 260760-M16807410025 260760-M16807410026 260760-M16807410002 260760-M16807410014 260760-M16807410001 260760-M16807410024 260760-M16907000044 260760-M16907000043 260760-M16907000042 260760-M16907000041 260760-M16907000040 260760-M16907000039 260760-M16907000038 260760-M16907000037 260760-M16907000036 260760-M16907000035 260760-M16907000034 260760-M16907000033 260760-M16907000032 260760-M16907000031 260760-M16907000030 260760-M16907000029 260760-M16907000028 260760-M16907000027 260760-M16907000026 260760-M16907000025 260760-M16907000024 260760-M16907000023 260760-M16907000022 260760-M16907000021 260760-M16907000020 260760-M16907000019 260760-M16907000018 260760-M16907000015 260760-M16907000017 260760-M16907000016 260760-M16907000013 260760-M16907000001 260760-M16907000002 260760-M16907000003 260760-M16907000004 260760-M16907000005 260760-M16907000006 260760-M16907000007 260760-M16907000008 260760-M16907000009 260760-M16907000012 260760-M16907000011 260760-M16907000014 260760-M16907000010 260727-M16704280010 260727-M16704280031 260727-M16704280024 260727-M16704280028 260727-M16704280023 260727-M16704280032 260727-M16704280027 260727-M16704280026 260727-M16704280022 260727-M16704280021 260727-M16704280020 260727-M16704280018 260727-M16704280017 260727-M16704280016 260727-M16704280015 260727-M16704280014 260727-M16704280025 260727-M16704280001 260727-M16704280003 260727-M16704280008 260727-M16704280013 260727-M16704280034 260727-M16704280101 260727-M16704280036 260727-M16704280108 260727-M16704280107 260727-M16704280106 260727-M16704280105 260727-M16704280104 260727-M16704280103 260727-M16704280029 260727-M16704280099 260727-M16704280097 260727-M16704280095 260727-M16704280035 260727-M16704280085 260727-M16704280081 260727-M16704280077 260727-M16704280090 260727-M16704280054 260727-M16704280037 260727-M16704280038 260727-M16704280062 260727-M16704280040 260727-M16704280041 260727-M16704280042 260727-M16704280039 260727-M16704280044 260727-M16704280046 260727-M16704280047 260727-M16704280048 260727-M16704280050 260727-M16704280043 260727-M16704280030 261023-M16B03030002 261023-M16B03030001 260084-M16B03200001 260084-M16B03200003 260760-M16B03190015 260760-M16B03190016 260760-M16B03190017 260760-M16B03190018 260760-M16B03190019 260760-M16B03190020 260760-M16B03190021 260760-M16B03190022 260760-M16B03190023 260760-M16B03190024 260760-M16B03190025 260760-M16B03190026 260760-M16B03190027 260760-M16B03190028 260760-M16B03190029 260760-M16B03190030 260760-M16B03190031 260084-M16B03200002 260760-M16B03190033 260760-M16B03190034 260760-M16B03190035 260760-M16B03190036 260760-M16B03190037 260760-M16B03190038 260760-M16B03190039 260760-M16B03190014 260760-M16B03190013 260760-M16B03190032 260760-M16B03190011 260760-M16B03190012 260084-M16B03200005 260084-M16B03200006 260084-M16B03200007 260084-M16B03200008 260084-M16B03200009 260084-M16B03200010 260084-M16B03200011 260084-M16B03200012 260084-M16B03200013 260084-M16B03200014 260084-M16B03200015 260084-M16B03200016 260084-M16B03200004 260084-M16B03200018 260084-M16B03200017 260760-M16B03190009 260760-M16B03190008 260760-M16B03190006 260760-M16B03190005 260760-M16B03190007 260760-M16B03190003 260760-M16B03190002 260760-M16B03190001 260084-M16B03200020 260084-M16B03200019 260760-M16B03190004 260760-M16B03190010 260760-M16B08990011 260760-M16B08990012 260727-M16704280078 260727-M16704280079 260727-M16704280076 260727-M16704280075 260727-M16704280074 260727-M16704280073 260727-M16704280072 260727-M16704280071 260727-M16704280070 260727-M16704280069 260727-M16704280068 260727-M16704280067 260727-M16704280066 260727-M16704280065 260727-M16704280064 260727-M16704280063 260727-M16704280061 260727-M16704280060 260727-M16704280059 260727-M16704280058 260727-M16704280057 260727-M16704280056 260727-M16704280055 260727-M16704280053 260727-M16704280052 260727-M16704280051 260727-M16704280080 260727-M16704280045 260727-M16704280082 260727-M16704280084 260760-M16B08990010 260760-M16B08990009 260760-M16B08990008 260760-M16B08990007 260760-M16B08990006 260760-M16B08990005 260760-M16B08990004 260760-M16B08990003 260760-M16B08990002 260760-M16B08990001 260084-M16B09000003 260084-M16B09000002 260084-M16B09000001 260727-M16704280102 260727-M16704280100 260727-M16704280098 260727-M16704280096 260727-M16704280094 260727-M16704280093 260727-M16704280092 260727-M16704280091 260727-M16704280089 260727-M16704280088 260727-M16704280087 260727-M16704280086 260727-M16704280083 260727-M16704280033 260727-M16704280049 260727-M16704280012 260760-M16B08990039 260760-M16B08990038 260760-M16B08990037 260760-M16B08990036 260760-M16B08990035 260760-M16B08990034 260760-M16B08990033 260760-M16B08990032 260760-M16B08990031 260760-M16B08990030 260760-M16B08990029 260760-M16B08990028 260727-M16704280019 260760-M16B08990027 260760-M16B08990025 260760-M16B08990024 260760-M16B08990023 260760-M16B08990022 260760-M16B08990021 260760-M16B08990020 260760-M16B08990019 260760-M16B08990018 260760-M16B08990017 260760-M16B08990016 260760-M16B08990015 260760-M16B08990014 260760-M16B08990026 260760-M16B08990041 260760-M16B08990040 260727-M16704280011 260727-M16704280009 260727-M16704280007 260727-M16704280006 260727-M16704280005 260727-M16704280004 260727-M16704280002 260760-M16B08990013 261023-M16C08910003 261023-M16C08910002 261023-M16C08910001 260760-M16C08890025 260760-M16C08890024 260760-M16C08890022 260760-M16C08890023 260084-M16C08900001 260084-M16C08900003 260084-M16C08900004 260084-M16C08900005 260760-M16C08890001 260760-M16C08890002 260760-M16C08890003 260760-M16C08890004 260760-M16C08890005 260760-M16C08890006 260760-M16C08890007 260760-M16C08890008 260760-M16C08890009 260084-M16C08900002 260760-M16C08890011 260760-M16C08890010 260760-M16C08890020 260760-M16C08890019 260760-M16C08890021 260760-M16C08890017 260760-M16C08890018 261023-M16C08910004 260760-M16C08890015 260760-M16C08890014 260760-M16C08890013 260760-M16C08890012 260760-M16C08890016 260084-M16C12980008 260084-M16C12980001 260084-M16C12980006 260084-M16C12980035 260084-M16C12980036 260084-M16C12980022 260084-M16C12980028 260084-M16C12980037 260084-M16C12980038 260084-M16C12980002 260084-M16C12980011 260084-M16C12980027 260084-M16C12980032 260084-M16C12980017 260084-M16C12980031 260084-M16C12980007 260084-M16C12980020 260084-M16C12980024 260084-M16C12980029 260084-M16C12980005 260084-M16C12980013 260084-M16C12980023 260084-M16C12980012 260084-M16C12980009 260084-M16C12980015 260084-M16C12980016 260084-M16C12980018 260084-M16C12980030 260084-M16C12980034 260084-M16C12980033 260084-M16C12980003 260084-M16C12980010 260084-M16C12980014 260084-M16C12980039 260084-M16C12980021 260084-M16C12980004 260084-M16C12980019 260084-M16C12980026 260084-M16C12980040 260084-M16C12980025 260760-M17100750074 260760-M17100750072 260760-M17100750039 260760-M17100750075 260760-M17100750007 260760-M17100750008 260760-M17100750009 260760-M17100750010 260760-M17100750037 260760-M17100750038 260760-M17100750043 260760-M17100750081 260760-M17100750048 260760-M17100750049 260760-M17100750050 260760-M17100750082 260760-M17100750085 260760-M17100750092 260760-M17100750011 260760-M17100750015 260760-M17100750071 260760-M17100750014 260760-M17100750047 260760-M17100750058 260760-M17100750059 260760-M17100750056 260760-M17100750060 260760-M17100750021 260760-M17100750093 260760-M17100750098 260760-M17100750099 260760-M17100750100 260760-M17100750013 260760-M17100750018 260760-M17100750019 260760-M17100750023 260760-M17100750057 260760-M17100750029 260760-M17100750040 260760-M17100... |
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.