FDA Medical devices recall ·
EDAN Product Name: Patient Monitor Model recall
- Recall number
- Z-1154-2026
- 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
- 3141
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor 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 patient monitor supports software upgrade online and networking and build-in battery power is available for all the models. iM8 Series Patient Monitor can monitor physiological parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP. The above is the maximum configuration, the user may select different monitoring parameters in according with the requirement. iM8 Series patient monitor includes three models iM8, iM8A, iM8B, and screen size is the primary difference for three models. 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: iM8 UDI-DI code: 06944413801592 Serial/Lot Numbers: 260645-M15C07240016 260645-M15C07240001 260645-M15C07240004 260645-M15C07240005 260645-M15C07240017 260645-M15C07240006 260645-M15C07240007 260645-M15C07240008 260645-M15C07240015 260645-M15C07240009 260645-M15C07240018 260645-M15C07240019 260645-M15C07240020 260645-M15C07240010 260645-M15C07240011 260645-M15C07240012 260645-M15C07240013 260645-M15C07240014 260645-M15C07240002 260645-M15C07240003 260645-M16200530008 260645-M16200530007 260645-M16200530006 260645-M16200530005 260645-M16200530001 260645-M16200530003 260645-M16200530002 260645-M16200530004 260605-M16304610008 260605-M16304610010 260605-M16304610007 260605-M16304610009 260605-M16304610006 260605-M16304610001 260605-M16304610004 260605-M16304610003 260605-M16304610002 260605-M16304610005 260605-K16300150005 260605-K16300150006 260605-K16300150007 260605-K16300150008 260605-K16300150009 260605-K16300150010 260605-K16300150004 260645-M16203940001 260645-M16203940003 260645-M16203940005 260645-M16203940006 260645-M16203940007 260645-M16203940008 260645-M16203940002 260605-K16300150003 260605-K16300150002 260605-K16300150001 260645-M16203940009 260645-M16203940010 260645-M16203940004 260645-M16203940012 260645-M16203940011 260605-M16313860011 260605-M16313860018 260605-M16313860017 260605-M16313860016 260605-M16313860019 260605-M16313860015 260605-M16313860014 260605-M16313860013 260605-M16313860012 260605-M16313860010 260605-M16313860005 260605-M16313860
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-1154-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.