Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iH...
FDA Device Recall #Z-1144-2026 — Class II — October 24, 2025
Recall Summary
| Recall Number | Z-1144-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 24, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Edan Diagnostics |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | 136 |
Product Description
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics. Component: No
Reason for Recall
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.
Distribution Pattern
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.
Lot / Code Information
EDAN Model: iM3s UDI-DI code: 06944413811171 Serial/Lot Numbers: 262825-H24701480005 262825-H24701480001 262825-H24701480002 262825-H24701480007 262825-H24701480010 262825-H24701480009 262825-H24701480008 262825-H24701480004 262825-H24701480003 262825-H24701480006 262825-H24802410006 262825-H24802410003 262825-H24802410007 262825-H24802410009 262825-H24802410010 262825-H24802410002 262825-H24802410005 262825-H24802410001 262825-H24802410008 262825-H24802410004 261573-M21708880001 261573-M21803610001 261573-M21C04280007 261573-M21C04280003 261573-M21C04280004 261573-M21C04280008 261573-M21C04280002 261573-M21C04280012 261573-M21C04280011 261573-M21C04280010 261573-M21C04280009 261573-M21C04280006 261573-M21C04280013 261573-M21C04280001 261573-M21C04280014 261573-M21C04280005 261573-M21C04280015 261573-M22701100009 261573-M22701100014 261573-M22701100019 261573-M22701100022 261573-M22701100025 261573-M22701100004 261573-M22701100021 261573-M22701100018 261573-M22701100008 261573-M22701100001 261573-M22701100020 261573-M22701100012 261573-M22701100005 261573-M22701100002 261573-M22701100011 261573-M22701100024 261573-M22701100013 261573-M22701100015 261573-M22701100023 261573-M22701100017 261573-M22701100007 261573-M22701100016 261573-M22701100006 261573-M22701100010 261573-M22701100003 262825-M23810180001 262825-M23810180002 261572-M20101720006 263089-H24503150005 263089-H24503150003 263089-H24503150006 263089-H24503150001 263089-H24503150010 263089-H24503150002 263089-H24503150014 263089-H24503150008 263089-H24503150009 263089-H24503150013 263089-H24503150012 263089-H24503150007 263089-H24503150011 263089-H24503150004 263089-H24503150015 262825-H25300480002 262825-H25300480001 263163-H25401870003 263163-H25401870004 263089-H25502070002 263089-H25502070016 263163-H25401870007 263163-H25401870008 263163-H25401870005 263163-H25401870001 263163-H25401870002 263163-H25401870006 263163-H25401870010 262825-H25502470009 263089-H25502070008 263089-H25502070012 263089-H25502070015 263089-H25502070013 263089-H25502070006 263089-H25502070011 263089-H25502070017 263089-H25502070019 263089-H25502070004 263163-H25401870009 263089-H25502070010 263089-H25502070009 263089-H25502070007 263089-H25502070001 263089-H25502070018 263089-H25502070005 263089-H25502070003 262825-H25502470003 262825-H25502470002 262825-H25502470008 262825-H25502470001 262825-H25502470005 262825-H25502470006 262825-H25502470007 263089-H25502070014 262825-H25502470004 262825-H25502470010 263089-H25701330006 263089-H25701330008 263089-H25701330013 263089-H25701330004 263089-H25701330012 263089-H25701330014 263089-H25701330002 263089-H25701330015 263089-H25701330010 263089-H25701330007 263089-H25701330003 263089-H25701330001 263089-H25701330009 263089-H25701330011 263089-H25701330005
Other Recalls from Edan Diagnostics
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1140-2026 | Class II | Brand Name: EDAN Product Name: Fetal Monitor ... | Oct 24, 2025 |
| Z-1151-2026 | Class II | Brand Name: EDAN Product Name: Central Monitor... | Oct 24, 2025 |
| Z-1155-2026 | Class II | Brand Name: EDAN Product Name: Telemetry Trans... | Oct 24, 2025 |
| Z-1149-2026 | Class II | Brand Name: EDAN Product Name: Patient Monitor... | Oct 24, 2025 |
| Z-1146-2026 | Class II | Brand Name: EDAN Product Name: Patient Monitor... | Oct 24, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.