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RecallWatchMedical Device Safety
Class IIOngoingZ-1140-2026

Edan Diagnostics recalls Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2

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: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No

Lot / code information

Model
F3
UDI
code: 06944413800847 Serial/
Lot #
Code: 460085-M16105760001 460085-M16105760002 460085-M16105760003 460085-M16105760004 460085-M16105760005 460085-M16105760006 460085-M16105760007 460085-M16105760008 460085-M16105760009 460085-M161057…Show all
Code: 460085-M16105760001 460085-M16105760002 460085-M16105760003 460085-M16105760004 460085-M16105760005 460085-M16105760006 460085-M16105760007 460085-M16105760008 460085-M16105760009 460085-M16105760010 460085-M16105760011 460085-M16105760012 460085-M16105760013 460085-M16105760014 460085-M16105760015 460085-M16105760016 460085-M16105760017 460085-M16105760018 460085-M16105760019 460085-M16105760020 460085-M16105760021 460085-M16105760022 460085-M16105760023 460085-M16105760024 460085-M16105760025 460085-M16105760026 460085-M16105760027 460085-M16105760028 460085-M16105760029 460085-M16105760030 460085-M16105760031 460085-M16105760032 460085-M16105760033 460085-M16105760034 460085-M16105760035 460085-M16105760036 460085-M16105760037 460085-M16105760038 460085-M16105760039 460085-M16105760040 460085-M16105760041 460085-M16105760042 460085-M16105760043 460085-M16105760044 460085-M16105760045 460085-M16105760046 460085-M16105760047 460085-M16105760048 460085-M16105760049 460085-M16105760050 460085-M16105760051 460085-M16105760052 460085-M16105760053 460085-M16803010001 460085-M16803010002 460085-M16803010003 460085-M16803010004 460085-M16803010005 460085-M16803010006 460085-M16803010007 460085-M16803010008 460085-M16803010009 460085-M16803010010 460085-M16803010011 460085-M16803010012 460085-M16803010013 460085-M16803010014 460085-M16803010015 460085-M16803010016 460085-M16803010017 460085-M16803010018 460085-M16803010019 460085-M16803010020 460085-M16803010021 460085-M16803010022 460085-M16803010023 460085-M16803010024 460085-M16803010025 460085-M16803010026 460085-M16803010027 460085-M16803010028 460085-M16803010029 460085-M16803010030 460085-M16803010031 460085-M16803010032 460085-M16803010033 460085-M16803010034 460085-M16803010035 460085-M16803010036 460085-M16803010037 460085-M16803010038 460085-M16803010039 460085-M16803010040 460085-M16803010041 460085-M16803010042 460085-M16803010043 460085-M16803010044 460085-M16803010045 460085-M16803010046 460085-M16803010047 460085-M16803010048 460085-M16803010049 460085-M16803010050 460085-M16803010051 460085-M16803010052 460085-M16803010053 460085-M16803010054 460085-M16803010055 460085-M16803010056 460085-M16803010057 460085-M16803010058 460085-M16803010059 460085-M16803010060 460085-M16803010061 460085-M16803010062 460085-M16803010063 460085-M16803010064 460085-M16A04870001 460085-M16A04870002 460085-M16A04870003 460085-M16A04870004 460085-M16A04870005 460085-M16A04870006 460085-M16A04870007 460085-M16A04870008 460085-M16A04870009 460085-M16A04870010 460085-M16A04870011 460085-M16A04870012 460085-M16A04870013 460085-M16A04870014 460085-M16A04870015 460085-M16A04870016 460085-M16A04870017 460085-M16A04870018 460085-M16A04870019 460085-M16A04870020 460085-M16A04870021 460085-M16A04870022 460085-M16A04870023 460085-M16A04870024 460085-M16A04870025 460085-M16A04870026 460085-M16A04870027 460085-M16A04870028 460085-M16A04870029 460085-M16A04870030 460085-M16A04870031 460085-M16A04870032 460085-M16A04870033 460085-M16A04870034 460085-M16A04870035 460085-M16A04870036 460085-M16A04870037 460085-M16A04870038 460085-M16A04870039 460085-M16A04870040 460085-M16A04870041 460085-M16A04870042 460085-M16A04870043 460085-M16A04870044 460085-M16A04870045 460085-M16A04870046 460085-M16A04880001 460085-M16A04880002 460085-M16A04880003 460085-M16A04880004 460085-M16A04880005 460085-M16A04880006 460085-M16A04880007 460085-M16A04880008 460085-M16A04880009 460085-M16A04880010 460085-M16A04880011 460085-M16A04880012 460085-M16A04880013 460085-M16A04880014 460085-M16A04880015 460085-M16A04880016 460085-M16A04880017 460085-M16A04880018 460085-M16A04880019 460085-M16A04880020 460085-M16A04880021 460085-M16A04880022 460085-M16A04880023 460085-M16A04880024 460085-M16A04880025 460085-M16A04880026 460085-M16A04880027 460085-M16A04880028 460085-M16A04880029 460085-M16A04880030 460085-M16A04880031 460085-M16A04880032 460085-M16A04880033 460085-M16A04880034 460085-M16A04880035 460085-M16A04880036 460085-M16A04880037 460085-M16A04880038 460085-M16A04880039 460085-M16A04880040 460085-M16A04880041 460085-M16A04880042 460085-M16A04880043 460085-M16A04880044 460085-M16A04880045 460085-M16A04880046 460085-M16A04880047 460085-M16A04880048 460085-M16A04880049 460085-M16A04880050 460085-M17107980001 460085-M17107980002 460085-M17107980003 460085-M17107980004 460085-M17107980005 460085-M17107980006 460085-M17107980007 460085-M17107980008 460085-M17107980009 460085-M17107980010 460085-M17107980011 460085-M17107980012 460085-M17107980013 460085-M17107980014 460085-M17107980015 460085-M17602680001 460085-M17602680002 460085-M17602680003 460085-M17602680004 460085-M17602680005 460085-M17602680006 460085-M17602680007 460085-M17602680008 460085-M17602680009 460085-M17602680010 460085-M17602680011 460085-M17602680012 460085-M17602680013 460085-M17602680014 460085-M17602680015 460085-M17602680016 460085-M17602680017 460085-M17602680018 460085-M17602680019 460085-M17602680020 460085-M17602680021 460085-M17602680022 460085-M17602680023 460085-M17602680024 460085-M17602680025 460085-M17602680026 460085-M17602680027 460085-M17602680028 460085-M17602680029 460085-M17602680030 460085-M17602680031 460085-M17602680032 460085-M17602680033 460085-M17602680034 460085-M17602680035 460085-M17602680036 460085-M17602680037 460085-M17602680038 460085-M17602680039 460085-M17602680040 460085-M17602680041 460085-M17602680042 460085-M17602680043 460085-M17602680044 460085-M17602680045 460085-M17602680046 460085-M17602680047 460085-M17602680048 460085-M17602680049 460085-M17602680050 460085-M17602680051 460085-M17602680052 460085-M17602680053 460085-M17602680054 460085-M17602680055 460085-M17602680056 460085-M17602680057 460085-M17602680058 460085-M17602680059 460085-M17602680060 460085-M17602680061 460085-M17602680062 460085-M17602680063 460085-M17602680064 460085-M17602680065 460085-M17602680066 460085-M17602680067 460085-M17602680068 460085-M17602680069 460085-M17602680070 460085-M17602680071 460085-M176026 …
Additional code information

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461053-M23C17670040 461053-M23C17670041 461053-M23C17670042 461053-M23C17670043 461053-M23C17670044 461053-M23C17670045 461053-M23C17670046 461053-M23C17670047 461053-M23C17670048 461053-M23C17670049 461053-M23C17670050 461053-M23C17950001 461053-M23C17950002 461053-M23C17950003 461053-M23C17950004 461053-M23C17950005 461053-M23C17950006 461053-M23C17950007 461053-M23C17950008 461053-M23C17950009 461053-M23C17950010 461053-M23C17950011 461053-M23C17950012 461053-M23C17950013 461053-M23C17950014 461053-M23C17950015 461053-M23C17950016 461053-M23C17950017 461053-M23C17950018 461053-M23C17950019 461053-M23C17950020 461053-M23C17950021 461053-M23C17950022 461053-M23C17950023 461053-M23C17950024 461053-M23C17950025 461053-M23C17950026 461053-M23C17950027 461053-M23C17950028 461053-M23C17950029 461053-M23C17950030 461053-M23C17950031 461053-M23C17950032 461053-M23C17950033 461053-M23C17950034 461053-M23C17950035 461053-M23C17950036 461053-M23C17950037 461053-M23C17950038 461053-M23C17950039 461053-M23C17950040 461053-M23C17950041 461053-M23C17950042 461053-M23C17950043 461053-M23C17950044 461053-M23C17950045 461053-M23C17950046 461053-M23C17950047 461053-M23C17950048 461053-M23C17950049 461053-M23C17950050 461053-M23C17960001 461053-M23C17960002 461053-M23C17960003 461053-M23C17960004 461053-M23C17960005 461053-M23C17960006 461053-M23C17960007 461053-M23C17960008 461053-M23C17960009 461053-M23C17960010 461053-M23C17960011 461053-M23C17960012 461053-M23C17960013 461053-M23C17960014 461053-M23C17960015 461053-M23C17960016 461053-M23C17960017 461053-M23C17960018 461053-M23C17960019 461053-M23C17960020 461053-M23C17960021 461053-M23C17960022 461053-M23C17960023 461053-M23C17960024 461053-M23C17960025 461053-M23C17960026 461053-M23C17960027 461053-M23C17960028 461053-M23C17960029 461053-M23C17960030 461053-M23C17960031 461053-M23C17960032 461053-M23C17960033 461053-M23C17960034 461053-M23C17960035 461053-M23C17960036 461053-M23C17960037 461053-M23C17960038 461053-M23C17960039 461053-M23C17960040 461053-M23C17960041 461053-M23C17960042 461053-M23C17960043 461053-M23C17960044 461053-M23C17960045 461053-M23C17960046 461053-M23C17960047 461053-M23C17960048 461053-M23C17960049 461053-M23C17960050 461053-M25611990001 461053-M25611990002 461053-M25611990003 461053-M25611990004 461053-M25611990005 461053-M25611990006 461053-M25611990007 461053-M25611990008 461053-M25611990009 461053-M25611990010 461053-M25611990011 461053-M25611990012 461053-M25611990013 461053-M25611990014 461053-M25611990015 461053-M25611990016 461053-M25611990017 461053-M25611990018 461053-M25611990019 461053-M25611990020 461053-M25611990021 461053-M25611990022 461053-M25611990023 461053-M25611990024 461053-M25611990025 461053-M25611990026 461053-M25611990027 461053-M25611990028 461053-M25611990029 461053-M25611990030 461053-M25611990031 461053-M25611990032 461053-M25611990033 461053-M25611990034 461053-M25611990035 461053-M25611990036 461053-M25611990037 461053-M25611990038 461053-M25611990039 461053-M25611990040 461053-M25611990041 461053-M25611990042 461053-M25611990043 461053-M25611990044 461053-M25611990045 461053-M25611990046 461053-M25611990047 461053-M25611990048 461053-M25611990049 461053-M25611990050 461053-M25611990051 461053-M25611990052 461053-M25611990053 461053-M25611990054 461053-M25611990055 461053-M25611990056 461053-M25611990057 461053-M25611990058 461053-M25611990059 461234-M22603160001 560034-M17812060001 560034-M18700480001 560034-M18908300001 560034-M18908300002 560034-M20405450001 560034-M20809580001 560034-M20B12040001 560034-M20C16880001 560034-M22406140001 560034-M23401580001 EDAN Model: F2 UDI-DI code: 06944413800861 Serial/Lot Numbers: 460305-M15B02670001 460305-M15B02670002 460305-M15B02670003 460305-M15B02670004 460305-M15B02670005 460305-M16103460001 460305-M16103460002 460305-M16103460003 460305-M16103460004 460305-M16103460005 460540-M16900210001 460540-M16900210002 460540-M16900210003 460540-M16900210004 460540-M16900210005 460324-M16B07150 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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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