Brand Name: EDAN Product Name: Vital Signs Monitor
Medical device recall Z-1144-2026. 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
- 136 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: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics. Component: No
136, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
EDAN Model: iM3s UDI-DI code: 06944413811171 Serial/Lot Numbers: 262825-H24701480005 262825-H24701480001 262825-H24701480002 262825-H24701480007 262825-H24701480010 262825-H24701480009 262825-H24701480008 262825-H24701480004…
Every code shown here, 1,985 characters
EDAN Model: iM3s UDI-DI code: 06944413811171 Serial/Lot Numbers: 262825-H24701480005 262825-H24701480001 262825-H24701480002 262825-H24701480007 262825-H24701480010 262825-H24701480009 262825-H24701480008 262825-H24701480004 262825-H24701480003 262825-H24701480006 262825-H24802410006 262825-H24802410003 262825-H24802410007 262825-H24802410009 262825-H24802410010 262825-H24802410002 262825-H24802410005 262825-H24802410001 262825-H24802410008 262825-H24802410004 261573-M21708880001 261573-M21803610001 261573-M21C04280007 261573-M21C04280003 261573-M21C04280004 261573-M21C04280008 261573-M21C04280002 261573-M21C04280012 261573-M21C04280011 261573-M21C04280010 261573-M21C04280009 261573-M21C04280006 261573-M21C04280013 261573-M21C04280001 261573-M21C04280014 261573-M21C04280005 261573-M21C04280015 261573-M22701100009 261573-M22701100014 261573-M22701100019 261573-M22701100022 261573-M22701100025 261573-M22701100004 261573-M22701100021 261573-M22701100018 261573-M22701100008 261573-M22701100001 261573-M22701100020 261573-M22701100012 261573-M22701100005 261573-M22701100002 261573-M22701100011 261573-M22701100024 261573-M22701100013 261573-M22701100015 261573-M22701100023 261573-M22701100017 261573-M22701100007 261573-M22701100016 261573-M22701100006 261573-M22701100010 261573-M22701100003 262825-M23810180001 262825-M23810180002 261572-M20101720006 263089-H24503150005 263089-H24503150003 263089-H24503150006 263089-H24503150001 263089-H24503150010 263089-H24503150002 263089-H24503150014 263089-H24503150008 263089-H24503150009 263089-H24503150013 263089-H24503150012 263089-H24503150007 263089-H24503150011 263089-H24503150004 263089-H24503150015 262825-H25300480002 262825-H25300480001 263163-H25401870003 263163-H25401870004 263089-H25502070002 263089-H25502070016 263163-H25401870007 263163-H25401870008 263163-H25401870005 263163-H25401870001 263163-H25401870002 263163-H25401870006 263163-H25401870010 262825-H25502470009 263089-H25502070008 263089-H25502070012…
FDA’s list runs to 2,784 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 2,784 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.