Brand Name: EDAN Product Name: Central Monitoring System
Medical device recall Z-1151-2026. 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
- 395 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: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records and operate with off-the-shelf software and hardware. Component: No
395, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
EDAN Model: MFM-CNS UDI-DI code: 06944413800236 Serial/Lot Numbers: 460793-M18C12290001 460793-M19109170001 460793-M19200240001 460793-M19411950001 460793-M19804210001 460793-M19912750001 460793-M19B07530001 460793-M20809190001…
Every code shown here, 1,981 characters
EDAN Model: MFM-CNS UDI-DI code: 06944413800236 Serial/Lot Numbers: 460793-M18C12290001 460793-M19109170001 460793-M19200240001 460793-M19411950001 460793-M19804210001 460793-M19912750001 460793-M19B07530001 460793-M20809190001 460793-M20913190002 460793-M20913190001 460793-M20B19040001 460793-M21600070001 460793-M21603510001 460793-M24702870002 460793-M24702870001 460793-M25203640001 460793-M25314460001 460793-M25314460002 460793-M25610650001 460793-M25610650003 460793-M25610650002 EDAN Model: MFM-CNS Lite UDI-DI code: 06944413807983 Serial/Lot Numbers: 460570-M19710380001 460570-M19710370001 460570-M19A06460005 460570-M19A06460006 460570-M19A06460007 460570-M19A06460015 460570-M19A06460008 460570-M19A06460009 460570-M19A06460001 460570-M19A06460011 460570-M19A06460003 460570-M19A06460004 460570-M19A06460010 460570-M19A06460002 460570-M19A06460012 460570-M19A06460013 460570-M19A06460014 460570-M20602690001 460570-M20602690003 460570-M20602690002 460570-M20700020009 460570-M20700020002 460570-M20700020011 460570-M20700020012 460570-M20700020005 460570-M20700020007 460570-M20700020013 460570-M20700020008 460570-M20700020003 460570-M20700020004 460570-M20700020001 460570-M20700020010 460570-M20700020006 460570-M20807880003 460570-M20807880005 460570-M20807880001 460570-M20807880002 460570-M20807880004 460570-M20A08380001 460570-M20A08380004 460570-M20A08380005 460570-M20A08380002 460570-M20A08380003 460570-M20C16310008 460570-M20C16310009 460570-M20C16310010 460570-M20C16310004 460570-M20C16310006 460570-M20C16310001 460570-M20C16310002 460570-M20C16310003 460570-M20C16310005 460570-M20C16310007 460570-M24814460001 460570-M24814460002 460570-M24814460004 460570-M24814460003 460570-M24814460005 460570-M24B06920003 460570-M24B06920001 460570-M24B06920004 460570-M24B06920002 460570-M24B06920005 460570-M25216230002 460570-M25216230004 460570-M25216230005 460570-M25216230001 460570-M25216230006 460570-M25407560001 460570-M25407560002 460570-M25511390003…
FDA’s list runs to 8,040 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 8,040 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
-
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.