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RecallWatchMedical Device Safety
Class IIOngoingZ-1145-2026

Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50

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: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 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 abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No

Lot / code information

Model
iM50
UDI
code: 06944413801622 Serial/
Lot #
002327-M16803350001 002327-M16803350002 360069-M17707110001 333109-M16203920004 333109-M16203920005 333136-M16203910001 333136-M16203910002 333136-M16203910003 333136-M16203910004 333136-M16203910006…Show all
002327-M16803350001 002327-M16803350002 360069-M17707110001 333109-M16203920004 333109-M16203920005 333136-M16203910001 333136-M16203910002 333136-M16203910003 333136-M16203910004 333136-M16203910006 333136-M16203910007 333136-M16203910008 333136-M16203910009 333136-M16203910010 333136-M16203910005 333109-M16203920003 333109-M16203920002 333109-M16203920001 333109-M16802350004 333109-M16802350005 333109-M16802350006 333109-M16802350007 333109-M16802350008 333136-M16802360001 333136-M16802360002 333136-M16802360003 333136-M16802360004 333109-M16802350003 333136-M16802360005 333109-M16802350002 333109-M16802350001 333136-M16810700002 333136-M16810700003 333136-M16810700004 333136-M16810700005 333136-M16810700001 333136-M16A02590001 333136-M16A02590002 333136-M16A02590005 333136-M16A02590004 333136-M16A02590003 333136-M16A02590006 333136-M16A02590007 333136-M16A02590008 333136-M16A02590009 333136-M16A02590010 333136-M16B08530006 333136-M16B08530011 333136-M16B08530010 333136-M16B08530009 333136-M16B08530008 333136-M16B08530007 333136-M16B08530014 333136-M16B08530005 333136-M16B08530004 333136-M16B08530003 333136-M16B08530002 333136-M16B08530001 333109-M16B08540003 333109-M16B08540002 333109-M16B08540001 333136-M16B08530015 333136-M16B08530012 333136-M16B08530013 261054-M16C02640001 333136-M16B08550009 333136-M16B08550008 333136-M16B08550007 333136-M16B08550006 333136-M16B08550005 333136-M16B08550002 333136-M16B08550003 333136-M16B08550010 333136-M16B08550001 333109-M16B08560002 333109-M16B08560001 333136-M16B08550004 333136-M16B08550011 333136-M16B08550014 333136-M16B08550013 333136-M16B08550015 333136-M16B08550012 333109-M17201740005 333109-M17201740004 333109-M17201740003 333109-M17201740001 333109-M17201740002 261054-M17404380002 261054-M17404380001 261054-M17404380003 333152-M17606230003 333152-M17606230001 333152-M17606230004 333152-M17606230005 333152-M17606230002 333152-M17604540004 333152-M17604540005 333152-M17604540013 333152-M17604540007 333152-M17604540014 333152-M17604540001 333152-M17604540002 333152-M17604540010 333152-M17604540006 333152-M17604540012 333152-M17604540003 333152-M17604540011 333152-M17604540015 333152-M17604540008 333152-M17604540016 333152-M17604540009 333152-M17615040010 333152-M17615040004 333152-M17615040008 333152-M17615040003 333152-M17615040002 333152-M17615040005 333152-M17615040001 333152-M17615040009 333152-M17615040007 333152-M17615040006 333152-M17708870014 333152-M17708870004 333152-M17708870013 333152-M17708870005 333152-M17708870009 333153-M17708880003 333153-M17708880004 333153-M17708880005 333152-M17708870003 333152-M17708870011 333153-M17708880001 333152-M17708870001 333153-M17708880002 333152-M17708870012 333152-M17708870008 333152-M17708870006 333152-M17708870015 333152-M17708870007 333152-M17708870002 333152-M17708870010 333152-M17812870004 333153-M17812880003 333152-M17812870007 333152-M17812870006 333153-M17812880002 333152-M17812870001 333152-M17812870005 333152-M17812870003 333152-M17812870002 333153-M17812880001 333152-M17B07380003 333153-M17B07390010 333153-M17B07390009 333152-M17B07380007 333152-M17B07380005 333153-M17B07390007 333153-M17B07390005 333152-M17B07380014 333152-M17B07380013 333152-M17B07380011 333152-M17B07380004 333152-M17B07380009 333152-M17B07380015 333153-M17B07390004 333152-M17B07380006 333152-M17B07380002 333153-M17B07390008 333153-M17B07390002 333152-M17B07380010 333153-M17B07390003 333152-M17B07380012 333152-M17B07380008 333153-M17B07390001 333153-M17B07390006 333152-M17B07380001 261054-M17B09100003 261054-M17B09100002 261054-M17B09100004 261054-M17B09100001 333152-M18108230008 333152-M18108230007 333153-M18108210001 333153-M18108210002 333153-M18108210005 333152-M18108230001 261054-M18108220002 261054-M18108220001 333152-M18108230009 333152-M18108230005 333152-M18108230004 333152-M18108230010 333153-M18108210003 333153-M18108210004 333152-M18108230006 333152-M18108230003 333152-M18108230002 333152-M18407240003 333152-M18407240005 333152-M18407240002 261054-M18407250002 333152-M18407240001 261054-M18407250004 261054-M18407250003 261054-M18407250001 333152-M18407240004 261054-M18613120004 261054-M18613120003 333152-M18613390004 333152-M18613390005 333152-M18613390002 333152-M18613390001 261054-M18613120002 261054-M18613120001 333152-M18613390003 333152-M18803010006 333152-M18803010010 333152-M18803010004 261054-M18800810003 333152-M18803010002 261054-M18800810002 333152-M18803010007 333152-M18803010008 333152-M18803010009 261054-M18800810001 261054-M18800810004 333152-M18803010003 333152-M18803010001 333152-M18803010005 261054-M18901370001 261054-M18901370005 261054-M18901370007 261054-M18901370008 261054-M18901370003 261054-M18901370002 261054-M18901370006 261054-M18901370004 333152-M18A10630005 333153-M18A10640002 333152-M18A10630003 333153-M18A10640001 333152-M18A10630001 333152-M18A10630004 333152-M18A10630002 333152-M18C07440005 333152-M18C07440004 333152-M18C07440003 333152-M18C07440001 333152-M18C07440006 333152-M18C07440002 333152-M19306540002 333152-M19306540012 333152-M19306540001 333152-M19306540007 333152-M19306700003 333152-M19306700001 333152-M19306700006 333152-M19306540006 333152-M19306540008 333152-M19306540010 333152-M19306700007 333152-M19306540003 333152-M19306540004 333152-M19306540005 333152-M19306540011 333152-M19306540009 333152-M19306700008 333152-M19306700004 333152-M19306700002 333152-M19306700005 333153-M19306550002 333153-M19306550003 333153-M19306550008 333153-M19306550006 333153-M19306550007 333153-M19306550004 333153-M19306550009 333153-M19306550010 333153-M19306550001 333153-M19306550005 261054-M19403060003 261054-M19403060002 261054-M19403060001 333152-M19403070008 333152-M19403070007 333152-M19403070001 333152-M19403070006 333152-M19403070003 333152-M19403070005 333152-M19403070004 333152-M19403070002 333152-M19403070010 333152-M19403070009 333152-M19500980014 333152-M19500980001 333152-M19500980004 333152-M19500980011 333152-M19500980015 333152-M19500980005 333152-M19500980002 …
Additional code information

0010 333153-M17400810009 333153-M17400810014 333153-M17400810001 333153-M17400810003 333153-M17400810008 333153-M17400810012 333153-M17400810002 333153-M17400810007 333153-M17502580005 333153-M17502580015 333153-M17502580013 333153-M17502580019 333153-M17502580026 333153-M17502580034 333153-M17502580035 333153-M17502580030 333153-M17502580025 333153-M17502580007 333153-M17502580008 333153-M17502580012 333153-M17502580024 333153-M17502580004 333153-M17502580037 333153-M17502580038 333153-M17502580014 333153-M17502580021 333153-M17502580039 333153-M17502580032 333153-M17502580020 333153-M17502580017 333153-M17502580010 333153-M17502580022 333153-M17502580036 333153-M17502580001 333153-M17502580016 333153-M17502580027 333153-M17502580033 333153-M17502580028 333153-M17502580031 333153-M17502580002 333153-M17502580006 333153-M17502580023 333153-M17502580029 333153-M17502580003 333153-M17502580009 333153-M17502580011 333153-M17502580040 333153-M17502580018 333153-M17602270052 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333153-M17602270014 333153-M17602270022 333153-M17602270033 333153-M17602270038 333153-M17602270032 333153-M17602270031 333153-M17602270015 333153-M17602270007 333153-M17602270057 333152-M17610350006 333152-M17610350001 333152-M17610350008 333152-M17610350002 333152-M17610350010 333152-M17610350004 333152-M17610350007 333152-M17610350005 333152-M17610350009 333152-M17610350003 333152-M17807840008 333152-M17807840007 333152-M17807840004 333152-M17807840010 333152-M17807840005 333152-M17807840003 333152-M17807840001 333152-M17807840006 333152-M17807840002 333152-M17807840009 333153-M17A03210004 333153-M17A03210007 333153-M17A03210010 333153-M17A03210014 333153-M17A03210012 333153-M17A03210044 333153-M17A03210040 333153-M17A03210037 333153-M17A03210034 333153-M17A03210030 333153-M17A03210023 333153-M17A03210019 333153-M17A03210009 333153-M17A03210020 333153-M17A03210022 333153-M17A03210001 333153-M17A03210046 333153-M17A03210051 333153-M17A03210045 333153-M17A03210042 333153-M17A03210035 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333152-M18C05220006 333152-M18C05220003 333152-M18C05220005 333152-M18C05220002 333152-M18C05220001 333153-M19100850026 333153-M19100850027 333153-M19100850010 333153-M19100850018 333153-M19100850019 333153-M19100850007 333153-M19100850020 333153-M19100850028 333153-M19100850031 333153-M19100850032 333153-M19100850001 333153-M19100850002 333153-M19100850013 333153-M19100850029 333153-M19100850016 333153-M19100850005 333153-M19100850006 333153-M19100850008 333153-M19100850009 333153-M19100850011 333153-M19100850012 333153-M19100850023 333153-M19100850024 333153-M19100850015 333153-M19100850021 333153-M19100850003 333153-M19100850004 333153-M19100850017 333153-M19100850025 333153-M19100850033 333153-M19100850034 333153-M19100850030 333153-M19100850035 333153-M19100850022 333153-M19100850014 333153-M19110560005 333153-M19110560019 333153-M19110560024 333153-M19110560004 333153-M19110560025 333153-M19110560018 333153-M19110560016 333153-M19110560011 333153-M19110560012 333153-M19110560009 333153-M19110560028 333153-M19110560026 333153-M19110560010 333153-M19110560022 333153-M19110560014 333153-M19110560002 333153-M19110560001 333153-M19110560023 333153-M19110560008 333153-M19110560007 333153-M19110560006 333153-M19110560027 333153-M19110560021 333153-M19110560020 333153-M19110560003 333153-M19110560015 333153-M19110560017 333152-M19110550006 333152-M19110550002 333152-M19110550004 333152-M19110550005 333152-M19110550001 333153-M19110560013 333153-M19110560030 333153-M19110560029 333152-M19110550003 333152-M19314350010 333152-M19314350007 333152-M19314350004 333152-M19314350002 333152-M19314350009 333152-M19314350005 333152-M19314350003 333152-M19314350001 333152-M19314350006 333152-M19314350008 333153-M19403390030 333153-M19403390029 333153-M19403390023 333153-M19403390019 333153-M19403390013 333153-M19403390012 333153-M19403390003 333153-M19403390002 333153-M19403390021 333153-M19403390011 333153-M19403390009 333153-M19403390028 333153-M19403390018 333153-M19403390001 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333153-M19707200004 333153-M19707200013 333153-M19707200026 333153-M19707200033 333153-M19707200035 333153-M19707200020 333153-M20302670011 333153-M20302670037 333153-M20302670016 333153-M20302670023 333153-M20302670024 333153-M20302670025 333153-M20302670017 333153-M20302670018 333153-M20302670021 333153-M20302670022 333153-M20302670039 333153-M20302670013 333153-M20302670026 333153-M20302670006 333153-M20302670015 333153-M20302670031 333153-M20302670032 333153-M20302670040 333153-M20302670020 333153-M20302670038 333153-M20302670014 333153-M20302670008 333153-M20302670007 333153-M20302670009 333153-M20302670012 333153-M20302670027 333153-M20302670033 333153-M20302670034 333153-M20302670028 333153-M20302670029 333153-M20302670035 333153-M20302670019 333153-M20302670002 333153-M20302670010 333153-M20302670030 333153-M20302670036 333153-M20302670003 333153-M20302670004 333153-M20302670005 333153-M20302670001 333153-M20602280011 333153-M20602280039 333153-M20602280042 333153-M20602280050 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333153-M20602280066 333153-M20602280063 333153-M20602280019 333153-M20602280010 333153-M20602280057 333153-M20602280059 333153-M20602280078 333153-M20602280030 333153-M20602280073 333153-M20602280075 333153-M20602280080 333153-M20602280003 333153-M20602280022 333153-M20602280024 333153-M20602280054 333153-M20602280058 333153-M20602280034 333153-M20602280045 333153-M20602280076 333153-M20602280032 333153-M20602280038 333153-M20602280043 333153-M20602280052 333153-M20602280027 333153-M20602280074 333153-M20602280005 333152-M20709640004 333152-M20709640010 333152-M20709640005 333152-M20709640007 333152-M20709640009 333152-M20709640002 333152-M20709640001 333152-M20709640003 333152-M20709640006 333152-M20709640008 262188-M20C01710026 262188-M20C01710014 262188-M20C01710009 262188-M20C01710007 262188-M20C01710037 262188-M20C01710039 262188-M20C01710001 262188-M20C01710013 262188-M20C01710032 262188-M20C01710040 262188-M20C01710005 262188-M20C01710006 262188-M20C01710010 262188-M20C01710018 262188-M20C0171 …

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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