Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall EDAN

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall EDANsee related information
Date Initiated by FirmOctober 24, 2025
Date PostedJanuary 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1152-2026
Recall Event ID 97879
510(K)NumberK101539 
Product Classification Oximeter - Product Code DQA
ProductBrand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. Component: No
Code Information EDAN Model: M3B UDI-DI code: 06944413800625 Serial/Lot Numbers: 302135-M16304900001 302135-M16304900002 261184-K17400190004 261184-K17400190001 261184-K17400190006 261184-K17400190002 261184-K17400190005 261184-K17400190003 261184-M17A03040001 261184-M18502370001 360126-M18810390001 360126-M18A08360001 360126-M18B13740001 360126-M19302070001 360126-M19302070002 360126-M19302070004 360126-M19302070003 360126-M20310110001 360126-M20310110002 360126-M20507230004 360126-M20507230003 360126-M20507230002 360126-M20507230001 360126-M20507230010 360126-M20507230007 360126-M20507230006 360126-M20507230008 360126-M20507230009 360126-M20507230005 360126-M23226940004 360126-M23226940005 360126-M23226940003 360126-M23226940001 360126-M23226940002 360126-M24511420002 360126-M24511420001 360126-M24716380001 360126-M24716380002 360126-M24716380003 360126-M24716380004 360126-M24716380005 302135-M16403060001 302135-M16403060002 302135-M16403060003 302135-M16403060004 302135-M16901880001 302135-M16901880002 302135-M16901880003 360126-M19805440001 360126-M19805440002 360126-M19805440003 360126-M19805440004 360126-M20A13020002 360126-M20A13020001 360126-M20C18100001 360126-M21113380001 360126-M21404350001 360126-K23100140005 360126-K23100140004 360126-K23100140006 360126-K23100140001 360126-K23100140002 360126-K23100140003 360126-K23200180002 360126-K23200180003 360126-K23200180004 360126-M23222190005 360126-M23222190004 360126-M23222190002 360126-K23200180005 360126-K23200180001 360126-M23222190001 360126-M23222190003 360126-M23402080001 360126-M23402080004 360126-M23402080003 360126-M23402080002 360126-M23402080005 360126-M23402080006 360126-M23810550001 360126-M24308270001 302110-M15A04280003 302110-M15A04280004 302110-M15A04280005 302110-M15A04280002 302110-M15A04280001 302110-M15B04370012 302110-M15B04370013 302110-M15B04370015 302110-M15B04370001 302110-M15B04370002 302110-M15B04370003 302110-M15B04370004 302110-M15B04370007 302110-M15B04370006 302110-M15B04370014 302110-M15B04370008 302110-M15B04370009 302110-M15B04370010 302110-M15B04370011 302110-M15B04370005 260614-M15B05770001 302052-M15C01120005 302052-M15C01120004 302052-M15C01120003 302052-M15C01120001 302052-M15C01120002 302052-M16410920005 302052-M16410920004 302052-M16410920003 302052-M16410920002 302052-M16410920001 261036-M16B04590021 261036-M16B04590020 261036-M16B04590019 261036-M16B04590018 261036-M16B04590017 261036-M16B04590016 261036-M16B04590013 261036-M16B04590014 261036-M16B04590022 261036-M16B04590012 261036-M16B04590011 261036-M16B04590010 261036-M16B04590009 261036-M16B04590015 261036-M16B04590023 261036-M16B04590027 261036-M16B04590025 261036-M16B04590026 261036-M16B04590028 261036-M16B04590029 261036-M16B04590030 261036-M16B04590008 261036-M16B04590006 261036-M16B04590005 261036-M16B04590004 261036-M16B04590003 261036-M16B04590002 261036-M16B04590001 261036-M16B04590024 261036-M16B04590007 261038-M16B08500001 261038-M17101560001 261038-M17101560002 261038-M17101560004 261038-M17101560003 261038-M17101560005 260134-M17109090001 261036-M17207750009 261036-M17207750010 261036-M17207750001 261036-M17207750007 261036-M17207750008 261036-M17207750004 261036-M17207750006 261036-M17207750005 261036-M17207750003 261036-M17207750002 3021320-M17300950001 3021320-M17304090003 3021320-M17304090002 3021320-M17304090001 3021320-M17304100001 261036-M17309070013 261036-M17309070006 261036-M17309070019 261036-M17309070017 261036-M17309070011 261036-M17309070003 261036-M17309070020 261036-M17309070010 261036-M17309070018 261036-M17309070012 261036-M17309070004 261036-M17309070005 261036-M17309070009 261036-M17309070014 261036-M17309070008 261036-M17309070001 261036-M17309070002 261036-M17309070007 261036-M17309070015 261036-M17309070016 3021320-M17402010001 3021320-M17606210004 3021320-M17606210001 3021320-M17606210003 3021320-M17606210002 302121-M17806460005 302121-M17806460001 302121-M17806460003 302121-M17806460004 302121-M17806460002 261038-M18108080001 360126-M18112880003 360126-M18112880008 360126-M18112880009 360126-M18112880005 360126-M18112880004 360126-M18112880010 360126-M18112880001 360126-M18112880002 360126-M18112880007 360126-M18112880006 360126-M18412040001 360126-M18604830002 360126-M18604830003 360126-M18604830001 360126-M18702300003 360126-M18702310002 360126-M18702300001 360126-M18702310001 360126-M18702300002 360126-M18801960004 360126-M18801960003 360126-M18801960002 360126-M18801960001 360126-M18801960005 360126-M18A02130003 360126-M18A02130002 360126-M18A02130005 360126-M18A02130001 360126-M18A02130004 360126-M18C09380001 360126-M19106040003 360126-M19106040001 360126-M19106040002 360126-M19509260005 360126-M19509260004 360126-M19509260001 360126-M19509260002 360126-M19509260003 360126-M19A01920005 360126-M19A01920004 360126-M19A01920002 360126-M19A01920007 360126-M19A01920008 360126-M19A01920006 360126-M19A01920001 360126-M19A01920003 360126-M20201030001 360126-M20201030003 360126-M20200960001 360126-M20201030002 360126-M20302610002 360126-M20302610003 360126-M20302610001 360126-M20302610004 360126-M20302610005 360126-M20311810004 360126-M20311810002 360126-M20311810001 360126-M20311810003 360126-M20311810005 360126-M20901580005 360126-M20901580002 360126-M20901590002 360126-M20901580008 360126-M20901580004 360126-M20901580003 360126-M20901580006 360126-M20901590001 360126-M20901590004 360126-M20901590003 360126-M20901580001 360126-M20901580007 360126-M20A11050002 360126-M20917000001 360126-M20A11050003 360126-M20A11050001 360126-M20917000002 360126-M20917000003 360126-M21303960001 360126-M21A04060001 360126-M21A11760005 360126-M21A11760003 360126-M21A11760004 360126-M21A11760002 360126-M21A11760001 360126-K22300140003 360126-K22300140001 360126-K22300140002 360126-M22501100003 360126-M22501100002 360126-M22501100001 360126-M22502800001 360126-M22602220003 360126-M22602220005 360126-M22602220004 360126-M22602220006 360126-M22602220001 360126-M22602220002 360126-K23100010001 360126-M23303900001 360126-M23303900002 360126-M23705700004 360126-M23705700005 360126-M23705700003 360126-M23705700001 360126-M23705700002 360126-M23915730005 360126-M23915730001 360126-M23915730004 360126-M23915730003 360126-M23915730002 360126-M23C11060001 360126-M24203060005 360126-M24203060003 360126-M24203060008 360126-M24203060004 360126-M24203060002 360126-M24203060006 360126-M24203060001 360126-M24203060007 360126-M24406470001 360126-M24406470002 360126-M24522360001 360126-M24620910002 360126-M24620910004 360126-M24620910001 360126-M24620900001 360126-M24620910003 360126-M24620910005 360126-M24620900002 360126-M24C07650001 360126-M24C26040001 360126-M24C26050001 360126-M25206020001 360126-M25206020004 360126-M25206020002 360126-M25206020003 360126-M25209130003 360126-M25209130001 360126-M25209120002 360126-M25209120001 360126-M25209120003 360126-M25209130002 360126-M25303620001 360126-M25301720002 360126-M25301720005 360126-M25301720004 360126-M25301720003 360126-M25301720001 360126-M25216170003 360126-M25216170001 360126-M25216170002 360126-M25216170004 360126-M25216170005 360126-M25319470002 360126-M25319470003 360126-M25319470005 360126-M25319470001 360126-M25319470004
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 Commerce354
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 = DQA
-
-