FDA Medical devices recall ·
EDAN Product Name: Patient Monitor Model recall
- Recall number
- Z-1145-2026
- 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
- 14550
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 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 abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. 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: iM50 UDI-DI code: 06944413801622 Serial/Lot Numbers: 002327-M16803350001 002327-M16803350002 360069-M17707110001 333109-M16203920004 333109-M16203920005 333136-M16203910001 333136-M16203910002 333136-M16203910003 333136-M16203910004 333136-M16203910006 333136-M16203910007 333136-M16203910008 333136-M16203910009 333136-M16203910010 333136-M16203910005 333109-M16203920003 333109-M16203920002 333109-M16203920001 333109-M16802350004 333109-M16802350005 333109-M16802350006 333109-M16802350007 333109-M16802350008 333136-M16802360001 333136-M16802360002 333136-M16802360003 333136-M16802360004 333109-M16802350003 333136-M16802360005 333109-M16802350002 333109-M16802350001 333136-M16810700002 333136-M16810700003 333136-M16810700004 333136-M16810700005 333136-M16810700001 333136-M16A02590001 333136-M16A02590002 333136-M16A02590005 333136-M16A02590004 333136-M16A02590003 333136-M16A02590006 333136-M16A02590007 333136-M16A02590008 333136-M16A02590009 333136-M16A02590010 333136-M16B08530006 333136-M16B08530011 333136-M16B08530010 333136-M16B08530009 333136-M16B08530008 333136-M16B08530007 333136-M16B08530014 333136-M16B08530005 333136-M16B08530004 333136-M16B08530003 333136-M16B08530002 333136-M16B08530001 333109-M16B08540003 333109-M16B08540002 333109-M16B08540001 333136-M16B08530015 333136-M16B08530012 333136-M16B08530013 261054-M16C02640001 333136-M16B08550009 333136-M16B08550008 333136-M16B08550007 333136-M16B08550006 333136-M16B08550005 333136-M16B08550002 333136-M16B0855
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-1145-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.