Brand Name: EDAN Product Name: Patient Monitor
Medical device recall Z-1146-2026. 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
- 342 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: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography). Component: No
342, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
EDAN Model: elite V8 UDI-DI code: 06944413801707 Serial/Lot Numbers: 260342-M17B09290001 002338-M23226990001 002338-M23226990002 002338-M23226990004 002338-M23226990003 002338-M23812870001 002338-M23C15870001 002338-M24A12130001…
Every code shown here, 1,998 characters
EDAN Model: elite V8 UDI-DI code: 06944413801707 Serial/Lot Numbers: 260342-M17B09290001 002338-M23226990001 002338-M23226990002 002338-M23226990004 002338-M23226990003 002338-M23812870001 002338-M23C15870001 002338-M24A12130001 260342-M16506570001 260342-M15A03180001 002338-K22100150003 002338-K22100150004 002338-K22100150002 002338-K22100150001 261241-M22701020001 002338-M25705810020 002338-M25705810021 002338-M25705810011 002338-M25705810003 002338-M25705810013 002338-M25705810029 002338-M25705810033 002338-M25705810001 002338-M25705810010 002338-M25705810009 002338-M25705810004 002338-M25705810012 002338-M25705810018 002338-M25705810032 002338-M25705810017 002338-M25705810019 002338-M25705810024 002338-M25705810030 002338-M25705810031 002338-M25705810025 002338-M25705810016 002338-M25705810008 002338-M25705810006 002338-M25705810002 002338-M25705810028 002338-M25705810027 002338-M25705810022 002338-M25705810026 002338-M25705810023 002338-M25705810015 002338-M25705810014 002338-M25705810005 002338-M25705810007 002338-M25908680004 002338-M25908680003 002338-M25908680002 002338-M25908680001 EDAN Model: elite V5 UDI-DI code: 06944413802155 Serial/Lot Numbers: 260586-M17211520002 260586-M17211520006 260586-M17211520004 260586-M17211520008 260586-M17211520001 260586-M17211520009 260586-M17211520007 260586-M17211520003 260586-M17211520010 260586-M17211520005 260588-M17902120009 260588-M17902120002 260588-M17902120008 260588-M17902120001 260588-M17902120003 260588-M17902120006 260588-M17902120007 260588-M17902120004 260588-M17902120005 260588-M17902120010 260586-M19413090016 260586-M19413090007 260586-M19413090017 260586-M19413090006 260586-M19413090010 260586-M19413090014 260586-M19413090011 260586-M19413090008 260586-M19413090004 260586-M19413090019 260586-M19413090012 260586-M19413090003 260586-M19413090013 260586-M19413090009 260586-M19413090005 260586-M19413090002 260586-M19413090018 260586-M19413090001 260586-M19413090020 260586-M19413090015 260586-M19507110023…
FDA’s list runs to 7,046 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 7,046 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.