FDA Medical devices recall ·
EDAN Product Name: Fetal Monitor Model recall
- Recall number
- Z-1140-2026
- 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
- 3721
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. 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: F3 UDI-DI code: 06944413800847 Serial/Lot Code: 460085-M16105760001 460085-M16105760002 460085-M16105760003 460085-M16105760004 460085-M16105760005 460085-M16105760006 460085-M16105760007 460085-M16105760008 460085-M16105760009 460085-M16105760010 460085-M16105760011 460085-M16105760012 460085-M16105760013 460085-M16105760014 460085-M16105760015 460085-M16105760016 460085-M16105760017 460085-M16105760018 460085-M16105760019 460085-M16105760020 460085-M16105760021 460085-M16105760022 460085-M16105760023 460085-M16105760024 460085-M16105760025 460085-M16105760026 460085-M16105760027 460085-M16105760028 460085-M16105760029 460085-M16105760030 460085-M16105760031 460085-M16105760032 460085-M16105760033 460085-M16105760034 460085-M16105760035 460085-M16105760036 460085-M16105760037 460085-M16105760038 460085-M16105760039 460085-M16105760040 460085-M16105760041 460085-M16105760042 460085-M16105760043 460085-M16105760044 460085-M16105760045 460085-M16105760046 460085-M16105760047 460085-M16105760048 460085-M16105760049 460085-M16105760050 460085-M16105760051 460085-M16105760052 460085-M16105760053 460085-M16803010001 460085-M16803010002 460085-M16803010003 460085-M16803010004 460085-M16803010005 460085-M16803010006 460085-M16803010007 460085-M16803010008 460085-M16803010009 460085-M16803010010 460085-M16803010011 460085-M16803010012 460085-M16803010013 460085-M16803010014 460085-M16803010015 460085-M16803010016 460085-M16803010017 460085-M16803010018 460085-M16803010019
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-1140-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.