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U.S. Department of Health and Human Services

Class 2 Device Recall EDAN

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 Class 2 Device Recall EDANsee related information
Date Initiated by FirmOctober 24, 2025
Date PostedJanuary 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1144-2026
Recall Event ID 97879
510(K)NumberK202892 K233038 
Product Classification Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
ProductBrand 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
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
FEI Number 3009499478
Recalling Firm/
Manufacturer		 Edan Diagnostics
9833 Pacific Heights Blvd
San Diego CA 92121-4707
For Additional Information ContactChao Lin
858-7503066
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 10/24/2025, the firm emailed notifying customers of a product recall. On 11/06/2025, the firm emailed an "URGENT: MEDICAL DEVICE CORRECTION" Letter to customers informing them of labeling issues involving cybersecurity which arose from a communication from the U.S. Food & Drug Administration. -First issue involves an inappropriate publicly routable IP address that was used as an example in the user manual for demonstrating user-configurable IP settings and Second issue involves an inappropriate publicly IP address that was used as the factory default configuration. Customer are instructed to: 1. Immediately examine their inventory and quarantine product subject to correction. 2. If customers may have further distributed affected product, identify their customers and notify them at once of this product correction. The notification to their customers may be enhanced by including the enclosed URGENT MEDICAL DEVICE CORRECTION. 3. For affected product still in their inventory, place copy of the enclosed Notice Before Use and Corrigenda of User Manual into its package before distribution. 4. For affected product that has been distributed or is in use: (1) Confirm that they have received and acknowledged Corrigenda of User Manual. Print out a copy, attach to the User Manual. (2) Confirm the publicly routable IP address 202.114.4.* is NOT used in the User Maintain in the device. If 202.114.4.* is being used, change to appropriate IP settings of device in the Network Setup according to Instruction Instructions for IP Settings Configuration. 5. Complete the attached Acknowledgement and Receipt Form, sign it, and return a scanned copy to the sender of this notification by email. For questions - Contact: EDAN Instruments, Inc. Monday to Friday 09:00-17:00 (UTC+8) Tel:+86-0755-26898326 EDAN Diagnostics, Inc. Monday to Friday 09:00-17:00 (PST) Tel: 1-(858)-750-3066
Quantity in Commerce136
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MWI
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