FDA Medical devices recall ·
EDAN Product Name: Vital Signs Monitor Model recall
- Recall number
- Z-1153-2026
- Date
- (initiated October 24, 2025)
- Company / brand
- Edan Diagnostics
9833 Pacific Heights Blvd, San Diego, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12201
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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-M16408640
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: California Connecticut Florida Illinois Kentucky Louisiana Michigan North Carolina New York Pennsylvania Puerto Rico Rhode Island Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1153-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.