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RecallWatchMedical Device Safety
Class IIOngoingZ-1141-2026

Edan Diagnostics recalls Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6

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 & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express 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
F9
UDI
code: 06944413800434 Serial/
Lot #
460430-M16105660001 460430-M16700280001 460475-M16605590001 460475-M16605590002 460475-M16605590003 460475-M16605590004 460475-M16806530001 460475-M16806530002 460476-M16B07550001 460476-M16B07550002…Show all
460430-M16105660001 460430-M16700280001 460475-M16605590001 460475-M16605590002 460475-M16605590003 460475-M16605590004 460475-M16806530001 460475-M16806530002 460476-M16B07550001 460476-M16B07550002 460476-M16B07550003 460476-M17402630001 460476-M17402630002 460476-M17402630003 460476-M17402630004 460476-M17402630005 460476-M17607650001 460476-M17607650002 460476-M17607650003 460476-M17607650004 460476-M17607650005 460476-M17607650006 460476-M17607650007 460476-M17607650008 460476-M17607650009 460476-M17607650010 460517-M16804200001 460688-M17A07770001 460688-M17A07770002 460688-M17A07770003 460723-M17904190001 460945-M18200660001 460945-M18200660002 460945-M18200660003 460945-M18200660004 460945-M18200660005 460945-M18200660006 460945-M18200660007 460945-M18200660008 460945-M18200660009 460945-M18200660010 460945-M18200660011 460945-M18200660012 460945-M18200660013 460945-M18200660014 460945-M18200660015 460945-M18200660016 460945-M18200660017 460945-M18200660018 460945-M18200660019 460945-M18200660020 460945-M18200660021 460945-M18200660022 460945-M18200660023 460945-M18200660024 460945-M18200660025 460945-M18200660026 460945-M18200660027 460945-M18200660028 460945-M18200660029 460945-M18200660030 460945-M18200660031 460945-M18200660032 460956-M18504390001 460956-M18504390002 460956-M18504390003 460956-M18504390004 460956-M18504390005 460956-M18504390006 460956-M18504390007 460956-M18504390008 460956-M18504390009 460956-M18504390010 460956-M18504390011 460956-M18504390012 460956-M18504390013 460956-M18504390014 460956-M18504390015 460956-M18504390016 460956-M18504390017 460956-M18504390018 460956-M18504390019 460956-M18504390020 460956-M18504390021 460956-M18504390022 460956-M18504390023 460956-M18504390024 460956-M18504390025 460956-M18504390026 460956-M18504390027 460956-M18504390028 460956-M18504390029 460956-M18504390030 460956-M18504390031 460956-M18504390032 460956-M18700640001 460956-M18700640002 460956-M18700640003 460956-M18700640004 460956-M18700640005 460956-M18700640006 460956-M18700640007 460956-M18700640008 460956-M18700640009 460956-M18700640010 460956-M18700640011 460956-M18700640012 460956-M18700640013 460956-M18700640014 460956-M18700640015 460956-M18700640016 460956-M18700640017 460956-M18700640018 460956-M18700640019 460956-M18700640020 460956-M18803860001 460956-M18803860002 460956-M18803860003 460956-M18803860004 460956-M18803860005 460956-M18803860006 460956-M18803860007 460956-M18803860008 460956-M18B00450001 460956-M18B00450002 460956-M18B00450003 460956-M18B00450004 460956-M18B00450005 460956-M18B00450006 460956-M18B00450007 460956-M18B00450008 460956-M18B00450009 460956-M18B00450010 460956-M18B00450011 460956-M18B00450012 460956-M18B00450013 460956-M18B00450014 460956-M18B00450015 460956-M18B00450016 460956-M18B00450017 460956-M18B00450018 460956-M18B00450019 460956-M18B00450020 460956-M18B00450021 460956-M18B00450022 460956-M18B00450023 460956-M18B00450024 460956-M18B00450025 460956-M18B00450026 460956-M18B00450027 460956-M18B00450028 460956-M18B00450029 460956-M18B00450030 460956-M18B00450031 460956-M18B00450032 460956-M18B00450033 460956-M18B00450034 460956-M18B00450035 460956-M18B00450036 460956-M19312930001 460956-M19312930002 460956-M19312930003 460956-M19312930004 460956-M19312930005 460956-M19312930006 460956-M19312930007 460956-M19312930008 460956-M19312930009 460956-M19312930010 460956-M19312930011 460956-M19312930012 460956-M19312930013 460956-M19312930014 460956-M19312930015 460956-M19312930016 460956-M19312930017 460956-M19312930018 460956-M19312930019 460956-M19312930020 460956-M19703230001 460956-M19703230002 460956-M19703230003 460956-M19703230004 460956-M19703230005 460956-M19703230006 460956-M19703230007 460956-M19703230008 460956-M19703230009 460956-M19703230010 460956-M19703230011 460956-M19703230012 460956-M19703230013 460956-M19703230014 460956-M19703230015 460956-M19703230016 460956-M19703230017 460956-M19703230018 460956-M19703230019 460956-M19703230020 460956-M19703230021 460956-M19703230022 460956-M19703230023 460956-M19703230024 460956-M19703230025 460956-M19703230026 460956-M19703230027 460956-M19703230028 460956-M19703230029 460956-M19703230030 460956-M19703230031 460956-M19703230032 460956-M19703230033 460956-M19703230034 460956-M19703230035 460956-M19703230036 460956-M19703230037 460956-M19703230038 460956-M19703230039 460956-M19703230040 460956-M19703240001 460956-M19703240002 460956-M19703240003 460956-M19703240004 460956-M19703240005 460956-M19703240006 460956-M19703240007 460956-M19703240008 460956-M19703240009 460956-M19703240010 460956-M19703240011 460956-M19703240012 460956-M19703240013 460956-M19703240014 460956-M19703240015 460956-M19703240016 460956-M19703240017 460956-M19703240018 460956-M19703240019 460956-M19703240020 460956-M19703240021 460956-M19703240022 460956-M19703240023 460956-M19703240024 460956-M19703240025 460956-M19703240026 460956-M19703240027 460956-M19703240028 460956-M19703240029 460956-M19703240030 460956-M19703240031 460956-M19703240032 460956-M19703240033 460956-M19703240034 460956-M19703240035 460956-M19703240036 460956-M19703240037 460956-M19703240038 460956-M19704650001 460956-M19704650002 460956-M19704650003 460956-M19704650004 460956-M19704650005 460956-M19704650006 460956-M19704650007 460956-M19B01000001 460956-M19B01000002 460956-M19B01000003 460956-M19B01000004 460956-M19B01000005 460956-M19B01000006 460956-M19B01000007 460956-M19B01000008 460956-M19B01000009 460956-M19B01000010 460956-M19B01000011 460956-M19B01000012 460956-M19B01000013 460956-M19B01000014 460956-M19B01000015 460956-M19B01000016 460956-M19B01000017 460956-M19B01000018 460956-M19B01000019 460956-M19B01000020 460956-M19B01000021 460956-M19B01000022 460956-M19B01000023 460956-M19B01000024 460956-M19B01000025 460956-M19B01000026 460956-M19B01000027 460956-M19B01000028 460956-M19B01000029 460956-M19B01000030 460956-M19B01000031 460956-M19B01000032 460956-M19B01000033 460956-M19B01000034 460956-M19B01000035 460956-M19B01000036 …
Model
F9 Express
UDI
code: 06944413800441 Serial/
Lot #
560157-M15A03570001 460418-M15B07460001 460418-M16501740001 460418-M16405110001 460418-M16405110002 460418-M16405110003 460418-M16405110004 460418-M16405110005 460418-M16405110006 460418-M16405110007…Show all
560157-M15A03570001 460418-M15B07460001 460418-M16501740001 460418-M16405110001 460418-M16405110002 460418-M16405110003 460418-M16405110004 460418-M16405110005 460418-M16405110006 460418-M16405110007 460418-M16405110008 460418-M16405110009 460418-M16405110010 460418-M16405110011 460418-M16405110012 460288-M16702150001 460418-M16705790001 460418-M16705790002 460418-M16705790003 460418-M16705790004 460418-M16A07660001 460418-M16B00420001 460418-M16B00420002 460418-M16B00420003 460418-M16B00420004 460418-M16B00420005 460418-M16B00420006 460077-M16B04200001 460077-M16B04200002 460077-M16B04200003 460077-M16B04200004 460418-M16B13700001 460418-M16B13700002 460418-M16C08190001 460418-M16C08190004 460418-M16C08190003 460418-M16C08190005 460418-M16C08190002 460418-M17107420001 460418-M17107420002 460418-M17312480001 560039-M17906650005 560039-M17906650001 560039-M17906650004 560039-M17906650003 560039-M17906650002 460246-M15300540001 460497-M18313120002 460497-M18313120001 560039-M18706210004 560039-M18706210003 560039-M18706210001 560039-M18706210002 560039-M19109690001 560039-M19109690009 560039-M19109690012 560039-M19109690002 560039-M19109690003 560039-M19109690004 560039-M19109690015 560039-M19109690017 560039-M19109690008 560039-M19109690006 560039-M19109690013 560039-M19109690014 560039-M19109690020 560039-M19109690005 560039-M19109690011 560039-M19109690016 560039-M19109690007 560039-M19109690018 560039-M19109690019 560039-M19109690010 560039-M19412210007 560039-M19412210006 560039-M19412210001 560039-M19412210003 560039-M19412210008 560039-M19412210005 560039-M19412210002 560039-M19412210004 560039-M19706090001 560039-M19706090002 560039-M19706090005 560039-M19706090003 560039-M19706090004 560039-M19804740007 560039-M19804740008 560039-M19804740009 560039-M19804740011 560039-M19804740012 560039-M19804740020 560039-M19804740003 560039-M19804740004 560039-M19804740005 560039-M19804740018 560039-M19804740019 560039-M19804740021 560039-M19804740022 560039-M19804740017 560039-M19804740001 560039-M19804740002 560039-M19804740010 560039-M19804740016 560039-M19804740023 560039-M19804740024 560039-M19804740025 560039-M19804740006 560039-M19804740013 560039-M19804740014 560039-M19804740015 460995-M19902020002 460995-M19902020004 460995-M19902020005 460995-M19902020001 460995-M19902020003 560039-M19A01380001 560039-M19C16250001 560039-M19C16250003 560039-M19C16250002 560039-M19C16250004 560039-M20304960001 560039-M20C00690001 560039-M20C00680004 560039-M20C00680005 560039-M20C00680001 560039-M20C00680003 560039-M20C00680002 460984-M21107550002 460984-M21107550001 560039-M21700780010 560039-M21700780007 560039-M21700780008 560039-M21700780001 560039-M21700780002 560039-M21700780009 560039-M21700780003 560039-M21700780006 560039-M21700780011 560039-M21700780012 560039-M21700780004 560039-M21700780005 560039-M21C11330012 560039-M21C11330014 560039-M21C11330015 560039-M21C11330007 560039-M21C11330003 560039-M21C11330008 560039-M21C11330010 560039-M21C11330009 560039-M21C11330013 560039-M21C11330002 560039-M21C11330004 560039-M21C11330005 560039-M21C11330001 560039-M21C11330006 560039-M21C11330011 560039-M22204450005 560039-M22204450001 560039-M22204450002 560039-M22204450003 560039-M22204450004 460984-M22208630003 460984-M22208630002 460984-M22208630001 460995-M22508300006 460995-M22508300001 460995-M22508300003 460995-M22508300005 460995-M22508300002 460995-M22508300004 460984-M22708780003 460984-M22708780002 460984-M22708780001 460984-M22708780004 460984-M22800330002 460984-M22800330001 460984-M22800330005 560039-M23314110001 560039-M23314110002 560039-M23403990001 460984-M23713910001 460984-M23713910003 460984-M23713910004 460984-M23713910006 460984-M23713910007 460984-M23713910005 560039-K23900060001 560039-M23909480001 560039-M23909480002 560039-M23B04830006 560039-M23B04830005 560039-M23B04830003 560039-M23B04830001 560039-M23B04830002 560039-M23B04830004 560039-M23C12960002 560039-M23C12960004 560039-M23C12960005 560039-M23C12960001 560039-M23C12960003 560039-M23B19510004 560039-M23B19510005 560039-M23B19510006 560039-M23B19510003 560039-M23B19510001 560039-M23B19510002 560039-M24407390004 560039-M24407390005 560039-M24407390001 560039-M24407390002 560039-K24400290002 560039-K24400290001 560039-M24407390003 560039-K24400270001 460977-M24518330001 460977-M24518330002 460977-M24518330006 460977-M24518330007 460977-M24518330009 460977-M24518330013 460977-M24518330004 460977-M24518330008 460977-M24518330012 460977-M24518330003 460977-M24518330005 460977-M24518330010 460977-M24518330011 560039-M24706730004 560039-M24706730002 560039-M24706730007 560039-M24706730006 560039-M24706730001 560039-M24706730005 560039-M24706730003 560039-M24A17700001 560039-M24A17700002 560039-M24A17700007 560039-M24A17700008 560039-M24A17700009 560039-M24A17700003 560039-M24A17700004 560039-M24A17700005 560039-M24A17700006 560039-M24C01220001 560039-M24C01220002 560039-M24C01220005 560039-M24C01220018 560039-M24C01220019 560039-M24C01220007 560039-M24C01220009 560039-M24C01220013 560039-M24C01220014 560039-M24C01220016 560039-M24C01220003 560039-M24C01220004 560039-M24C01220006 560039-M24C01220010 560039-M24C01220017 560039-M24C01220008 560039-M24C01220011 560039-M24C01220012 560039-M24C01220015 560039-M24C01220020 560039-M24C15030003 560039-M24C15030011 560039-M24C15030004 560039-M24C15030005 560039-M24C15030001 560039-M24C15030006 560039-M24C15030009 560039-M24C15030010 560039-M24C15030002 560039-M24C15030007 560039-M24C15030008 560039-M24C18150001 461291-M25623120002 461291-M25623120004 461291-M25623120001 461291-M25623120003 EDAN
Model
F6
UDI
code: 06944413800458 Serial/
Lot #
560177-M15A03580001 560177-M15A03580002 560177-M15A03580003 560198-M15A03590001 560198-M15A03590002 560198-M15A03590003 560198-M15A03590004 560198-M15A03590005 560202-M15A03690001 560202-M15A03690002…Show all
560177-M15A03580001 560177-M15A03580002 560177-M15A03580003 560198-M15A03590001 560198-M15A03590002 560198-M15A03590003 560198-M15A03590004 560198-M15A03590005 560202-M15A03690001 560202-M15A03690002 560202-M15A03690003 560202-M15A03690004 560202-M15A03690005 560202-M15A03690006 560202-M15A06640001 560202-M15A06640002 560202-M15A06640003 560202-M15A06660001 560202-M15A06660002 560202-M15A06660003 560202-M15A06660004 560202-M15A06660005 560202-M15A06660006 560202-M15A06660007 560202-M15A06660008 560202-M15A06660009 560202-M15A06660010 560202-M15A06660011 5
Additional code information

60202-M15A06660012 460410-M15B00900001 460410-M15B00900002 460410-M15B00900003 460059-M15B03800001 460059-M15B03800002 460410-M15B03790001 460410-M15B03790002 460410-M15B03790003 460410-M15B03790004 460410-M15B03790005 460410-M15B03790006 460410-M15B03790007 560202-M15B10660001 560202-M15B10660002 560202-M15B10660003 460438-M16105640001 460438-M16105640002 460438-M16105640003 460438-M16105640004 460437-M16203310001 460437-M16203310002 460437-M16203310003 460437-M16310460001 460437-M16310460002 460437-M16310460003 460437-M16310460004 460437-M16310460005 460489-M16402050001 460489-M16402050002 460489-M16402050003 460489-M16402050004 460489-M16402050005 460489-M16402050006 460489-M16402050007 460489-M16402050008 460489-M16402050009 460489-M16402050010 460438-M16410190001 460438-M16410190002 460434-M16410160001 460434-M16410160002 460434-M16410160003 460434-M16410160004 460434-M16410160005 460434-M16410160006 460434-M16410160007 460434-M16410160008 460434-M16410160009 460434-M16410160010 460437-M16501720001 460437-M16501720002 460437-M16501720003 460437-M16501720004 460437-M16501720005 460434-M16507280001 460434-M16507280002 460434-M16507280003 460434-M16507280004 460434-M16507280005 460434-M16507280006 460434-M16507280007 460434-M16507280008 460434-M16507280009 460434-M16507280010 460434-M16507280011 460434-M16507280012 460438-M16509640001 460438-M16509640002 460437-M16603210001 460437-M16603210002 460437-M16603210003 460437-M16603210004 460437-M16603210005 460437-M16603210006 460437-M16603210007 460437-M16603210008 460437-M16603210009 460437-M16603210010 460490-M16604310001 460490-M16604310002 460490-M16604310003 460490-M16604310004 460490-M16604310005 460437-M16607030001 460437-M16607030002 460421-M16701230001 460490-M16704940001 460490-M16704940002 460490-M16704940003 460490-M16704940004 460490-M16704940005 460490-M16704940006 460490-M16704940007 460490-M16704940008 460490-M16704940009 460490-M16704940010 460490-M16704940011 460490-M16704940012 460490-M16704940013 460490-M16704940014 460490-M16704940015 460490-M16704940016 460490-M16704940017 460490-M16704940018 460490-M16704940019 460490-M16704940020 460490-M16704940021 460490-M16704940022 460490-M16704940023 460490-M16704940024 460490-M16704940025 460437-M16705780001 460437-M16705780002 460437-M16705780003 460437-M16705780004 460437-M16705780005 460437-M16705780006 460437-M16705780007 460437-M16705780008 460438-M16806590001 460438-M16806590002 460438-M16806590003 460438-M16907710001 460438-M16907710002 460438-M16907710003 460438-M16907710004 460437-M16909200001 460437-M16909200002 460437-M16909200003 460437-M16909200004 460437-M16909200005 460437-M16909200006 460437-M16909200007 460437-M16909200008 460489-M16A03240001 460489-M16A03240002 460489-M16A03240003 460489-M16A03240004 460489-M16A03240005 460489-M16A03240006 460489-M16A03240007 460489-M16A03240008 460489-M16A03240009 460489-M16A03240010 460437-M16A07750001 460437-M16A07750002 460437-M16A07750003 460437-M16A07750004 460437-M16A07750005 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5 …

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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