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RecallWatchMedical Device Safety
Class IIOngoingZ-1144-2026

Edan Diagnostics recalls Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s

Edan DiagnosticsSan Diego, CA, United StatesReported Jan 28, 2026 · 5 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI codeModel iM3s
    136 affected lots
    262825-H24701480005262825-H24701480001262825-H24701480002262825-H24701480007262825-H24701480010262825-H24701480009262825-H24701480008262825-H24701480004
    +128 more262825-H24701480003262825-H24701480006262825-H24802410006262825-H24802410003262825-H24802410007262825-H24802410009262825-H24802410010262825-H24802410002262825-H24802410005262825-H24802410001262825-H24802410008262825-H24802410004261573-M21708880001261573-M21803610001261573-M21C04280007261573-M21C04280003261573-M21C04280004261573-M21C04280008261573-M21C04280002261573-M21C04280012261573-M21C04280011261573-M21C04280010261573-M21C04280009261573-M21C04280006261573-M21C04280013261573-M21C04280001261573-M21C04280014261573-M21C04280005261573-M21C04280015261573-M22701100009261573-M22701100014261573-M22701100019261573-M22701100022261573-M22701100025261573-M22701100004261573-M22701100021261573-M22701100018261573-M22701100008261573-M22701100001261573-M22701100020261573-M22701100012261573-M22701100005261573-M22701100002261573-M22701100011261573-M22701100024261573-M22701100013261573-M22701100015261573-M22701100023261573-M22701100017261573-M22701100007261573-M22701100016261573-M22701100006261573-M22701100010261573-M22701100003262825-M23810180001262825-M23810180002261572-M20101720006263089-H24503150005263089-H24503150003263089-H24503150006263089-H24503150001263089-H24503150010263089-H24503150002263089-H24503150014263089-H24503150008263089-H24503150009263089-H24503150013263089-H24503150012263089-H24503150007263089-H24503150011263089-H24503150004263089-H24503150015262825-H25300480002262825-H25300480001263163-H25401870003263163-H25401870004263089-H25502070002263089-H25502070016263163-H25401870007263163-H25401870008263163-H25401870005263163-H25401870001263163-H25401870002263163-H25401870006263163-H25401870010262825-H25502470009263089-H25502070008263089-H25502070012263089-H25502070015263089-H25502070013263089-H25502070006263089-H25502070011263089-H25502070017263089-H25502070019263089-H25502070004263163-H25401870009263089-H25502070010263089-H25502070009263089-H25502070007263089-H25502070001263089-H25502070018263089-H25502070005263089-H25502070003262825-H25502470003262825-H25502470002262825-H25502470008262825-H25502470001262825-H25502470005262825-H25502470006262825-H25502470007263089-H25502070014262825-H25502470004262825-H25502470010263089-H25701330006263089-H25701330008263089-H25701330013263089-H25701330004263089-H25701330012263089-H25701330014263089-H25701330002263089-H25701330015263089-H25701330010263089-H25701330007263089-H25701330003263089-H25701330001263089-H25701330009263089-H25701330011263089-H25701330005

What the firm is doing

On 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

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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