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RecallWatchMedical Device Safety
Class IIOngoingZ-1148-2026

Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8

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.

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) 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. Component: No

Lot / code information

Model
X8
UDI
code: 06944413810907 Serial/
Lot #
261586-M21116620010 261586-M21116620002 261586-M21116620007 261586-M21116620006 261586-M21116620009 261586-M21116630001 261586-M21116620008 261586-M21116620003 261586-M21116630005 261586-M21116630003…Show all
261586-M21116620010 261586-M21116620002 261586-M21116620007 261586-M21116620006 261586-M21116620009 261586-M21116630001 261586-M21116620008 261586-M21116620003 261586-M21116630005 261586-M21116630003 261586-M21116620004 261586-M21116620001 261586-M21116630004 261586-M21116630002 261586-M21116620005 261586-M21301970003 261586-M21301970004 261586-M21301960001 261586-M21301970005 261586-M21301960003 261586-M21301970002 261586-M21301970001 261586-M21301960002 261586-M21714500002 261586-M21714500001 261586-M21714500003 261586-M21816750005 261586-M21816750003 261586-M21816750002 261586-M21816750004 261586-M21816750001 261586-M22105750001 261586-M22105750007 261586-M22105750008 261586-M22105750010 261586-M22105750002 261586-M22105750005 261586-M22105750009 261586-M22105750006 261586-M22105750003 261586-M22105750004 261586-M22405430007 261586-M22405430001 261586-M22405430004 261586-M22405430010 261586-M22405430006 261586-M22405430009 261586-M22405430008 261586-M22405430003 261586-M22405430002 261586-M22405430005 261586-M22615270004 261586-M22615270005 261586-M22615270001 261586-M22615270002 261586-M22615270003 261586-M23226950003 261586-M23226950002 261586-M23226950004 261586-M23226950005 261586-M23226950001 261586-M23B18320003 261586-M23B18320004 261586-M23B18330001 261586-M23B18330002 261586-M23B18330003 261586-M23B18330004 261586-M23B18320001 261586-M23B18320005 261586-M23B18330005 261586-M23B18320002 261586-M23C15910003 261586-M23C15920001 261586-M23C15920005 261586-M23C15920004 261586-M23C15920009 261586-M23C15910002 261586-M23C15920010 261586-M23C15920002 261586-M23C15910001 261586-M23C15910005 261586-M23C15920006 261586-M23C15920003 261586-M23C15910004 261586-M23C15920008 261586-M23C15920007 261586-M24104080002 261586-M24104080010 261586-M24104080003 261586-M24104080004 261586-M24104080006 261586-M24104080001 261586-M24104080005 261586-M24104080008 261586-M24104080009 261586-M24104080007 261586-M20611590012 261586-M20611590007 261586-M20611570016 261586-M20611590017 261586-M20611590018 261586-M20611580019 261586-M20611590004 261586-M20611590006 261586-M20611580022 261586-M20611590011 261586-M20611580002 261586-M20611580007 261586-M20611580017 261586-M20611580009 261586-M20611590009 261586-M20611590008 261586-M20611590019 261586-M20611590003 261586-M20611570006 261586-M20611580024 261586-M20611560003 261586-M20611570017 261586-M20611570015 261586-M20611560017 261586-M20611560007 261586-M20611560025 261586-M20611560020 261586-M20611560014 261586-M20611560013 261586-M20611560004 261586-M20611560022 261586-M20611560021 261586-M20611560018 261586-M20611560009 261586-M20611580012 261586-M20611560008 261586-M20611560011 261586-M20611560010 261586-M20611560002 261586-M20611560001 261586-M20611560019 261586-M20611560015 261586-M20611560006 261586-M20611560005 261586-M20611560024 261586-M20611560023 261586-M20611560012 261586-M20611590005 261586-M20611580015 261586-M20611580025 261586-M20611560016 261586-M20611580014 261586-M20611570002 261586-M20611580004 261586-M20611580005 261586-M20611590010 261586-M20611590013 261586-M20611590014 261586-M20611590015 261586-M20611590016 261586-M20611570001 261586-M20611570005 261586-M20611570007 261586-M20611570009 261586-M20611570019 261586-M20611580003 261586-M20611580013 261586-M20611580018 261586-M20611570010 261586-M20611570012 261586-M20611570018 261586-M20611570020 261586-M20611580006 261586-M20611580016 261586-M20611580023 261586-M20611590002 261586-M20611590001 261586-M20611590020 261586-M20611580020 261586-M20611580021 261586-M20611570004 261586-M20611580001 261586-M20611580010 261586-M20611570008 261586-M20611570003 261586-M20611570011 261586-M20611570013 261586-M20611580008 261586-M20611580011 261586-M20611570014 261586-M21313600009 261586-M21313600020 261586-M21313600017 261586-M21313600013 261586-M21313600010 261586-M21313600007 261586-M21313600024 261586-M21313600006 261586-M21313600023 261586-M21313600021 261586-M21313600015 261586-M21313600005 261586-M21313600025 261586-M21313600022 261586-M21313600008 261586-M21313600018 261586-M21313600016 261586-M21313600012 261586-M21313600011 261586-M21313600004 261586-M21313600003 261586-M21313600002 261586-M21313600001 261586-M21313600014 261586-M21313600019 261586-M21409420001 261586-M21409420015 261586-M21409420014 261586-M21409420005 261586-M21409420004 261586-M21409420008 261586-M21409420007 261586-M21409420009 261586-M21409420003 261586-M21409420013 261586-M21409420010 261586-M21409420012 261586-M21409420011 261586-M21409420006 261586-M21409420002 261586-M21808840003 261586-M21808840004 261586-M21808840005 261586-M21808840002 261586-M21808840009 261586-M21808840006 261586-M21808840010 261586-M21808840016 261586-M21808840013 261586-M21808840014 261586-M21808840015 261586-M21808840001 261586-M21808840007 261586-M21808840008 261586-M21808840011 261586-M21808840012 261586-M21808840018 261586-M21808840019 261586-M21808840020 261586-M21808840017 261586-M21903040001 261586-M21903040011 261586-M21903040004 261586-M21903040008 261586-M21903040005 261586-M21903040003 261586-M21903040012 261586-M21903040009 261586-M21903040007 261586-M21903040006 261586-M21903040002 261586-M21903040010 261586-M21903520014 261586-M21903520015 261586-M21903520019 261586-M21903520003 261586-M21903520004 261586-M21903520005 261586-M21903520009 261586-M21903520012 261586-M21903520020 261586-M21903520010 261586-M21903520017 261586-M21903520002 261586-M21903520008 261586-M21903520007 261586-M21903520006 261586-M21903520011 261586-M21903520016 261586-M21903520018 261586-M21903520013 261586-M21903520001 261586-M22102040002 261586-M22102040001 261586-M22102040006 261586-M22102040003 261586-M22102040020 261586-M22102040016 261586-M22102040015 261586-M22102040013 261586-M22102040010 261586-M22102040008 261586-M22102040007 261586-M22102040017 261586-M22102040009 261586-M22102040018 261586-M22102040014 261586-M22102040011 261586-M22102040019 261586-M22102040004 261586-M22102040005 261586-M22102030014 261586-M22102040012 261586-M22102030009 …
Model
X10
UDI
code: 06944413810921 Serial/
Lot #
261590-M21116650004 261590-M21116640010 261590-M21116650001 261590-M21116640009 261590-M21116640002 261590-M21116640001 261590-M21116640008 261590-M21116640006 261590-M21116650003 261590-M21116640004…Show all
261590-M21116650004 261590-M21116640010 261590-M21116650001 261590-M21116640009 261590-M21116640002 261590-M21116640001 261590-M21116640008 261590-M21116640006 261590-M21116650003 261590-M21116640004 261590-M21116650005 261590-M21116640007 261590-M21116640003 261590-M21116640005 261590-M21116650002 261590-M21301930004 261590-M21301930003 261590-M21301930002 261590-M21301940001 261590-M21301940003 261590-M21301930005 261590-M21301930001 261590-M21301940002 261590-M21608900002 261590-M21608900001 261590-M21608900003 261590-M21608900004 261590-M21714510002 261590-M21714510005 261590-M21714510001 261590-M21714510003 261590-M21714510004 261590-M21816760004 261590-M21816760003 261590-M21816760005 261590-M21816760002 261590-M21816760001 261590-M21C04540001 261590-M21C04540005 261590-M21C04540009 261590-M21C04540003 261590-M21C04540004 261590-M21C04540007 261590-M21C04540015 261590-M21C04540006 261590-M21C04540010 261590-M21C04540013 261590-M21C04540014 261590-M21C04540008 261590-M21C04540012 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261590-M21113720038 261590-M21113720018 261590-M21113720017 261590-M21113710033 261590-M21113710003 261590-M21113720020 261590-M21113720014 261590-M21113720015 261590-M21113710020 261590-M21113720009 261590-M21113710039 261590-M21113710022 261590-M21113720039 261590-M21113720019 261590-M21113710024 261590-M21113710025 261590-M21113710040 261590-M21113720040 261590-M21113710029 261590-M21113720016 261590-M21113720030 261590-M21113710015 261590-M21113710023 261590-M21113720028 261590-M21113710035 261590-M21113710011 261590-M21113710016 261590-M21113710017 261590-M21113710018 261590-M21113710037 261590-M21113720007 261590-M21113720008 261590-M21113720029 261590-M21113720032 261590-M21113720031 261590-M21113710038 261590-M21113710026 261590-M21113720035 261590-M21113710021 261590-M21113720021 261590-M21113720034 261590-M21113710027 261590-M21113710032 261590-M21113710028 261590-M21113710019 261590-M21113720022 261590-M21113720011 261590-M21113710013 261590-M21113710005 261590-M21113710012 …
Additional code information

1440018 261590-M23911440006 261590-M23911440027 261590-M23911440038 261590-M23911440039 261590-M23911440040 261590-M23911440007 261590-M23911440024 261590-M23911440025 261590-M23911440031 261590-M23911440001 261590-M23911440033 261590-M23911440030 261590-M23911440026 261590-M23911440022 261590-M23911440021 261590-M23911440015 261590-M23911440014 261590-M23911440037 261590-M23911440002 261590-M23911440023 261590-M23911440005 261590-M23911440003 261590-M23911440011 261590-M23911440012 261590-M23911440016 261590-M23911440034 261590-M23911440035 261590-M23911440020 261590-M23911440008 261590-M23911440010 261590-M23911440013 261590-M23911440028 261590-M23911440029 261590-M23911440032 261590-M23911440036 261590-M23911440004 261590-M23911440009 261590-M23911440019 261590-M23910690005 261590-M23910690009 261590-M23910690003 261590-M23910690007 261590-M23910690004 261590-M23910690011 261590-M23910690014 261590-M23910690006 261590-M23910690002 261590-M23910690012 261590-M23910690010 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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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