Brand Name: EDAN Product Name: Vital Signs Monitor
Medical device recall Z-1143-2026. Published in FDA’s Enforcement Report on Jan 28, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 28, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 13 states named
- 11987 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
11987, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,984 characters
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…
FDA’s list runs to 239,810 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
13 states and territories.
Every one of them
- California
- Connecticut
- Florida
- Illinois
- Kentucky
- Louisiana
- Michigan
- North Carolina
- New York
- Pennsylvania
- Puerto Rico
- Rhode Island
- Texas
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 24, 2025.
- FDA classified it on Jan 22, 2026.
- FDA’s Enforcement Report published it on Jan 28, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Edan Diagnostics, of San Diego, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 239,810 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.