HIGH

EDAN Fetal Monitors Recalled Due to Cybersecurity Risk

EDAN recalled 3,721 fetal monitors on October 24, 2025, due to potential cybersecurity vulnerabilities. The affected models, F2 and F3, are used to monitor pregnant women and fetuses after 28 weeks of gestation. Healthcare providers must stop using these devices immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
October 24, 2025
Hazard Level
HIGH
Brand
Edan Diagnostics
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Edan Diagnostics or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled products include EDAN fetal monitors, models F2 and F3. They were distributed in the U.S. states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and in Mexico. The recall affects 3,721 units.

The Hazard

The recall stems from a letter from the FDA regarding potential cybersecurity issues. These vulnerabilities could compromise the safety and effectiveness of the monitors, posing risks to patients.

Reported Incidents

No injuries or incidents have been reported related to this specific recall. However, the potential for cybersecurity breaches raises significant safety concerns.

What to Do

Patients and healthcare providers should stop using the monitors immediately. Contact Edan Diagnostics or your healthcare provider for further instructions on the recall.

Contact Information

For more information, contact Edan Diagnostics at [insert phone number] or visit their website at [insert website].

Key Facts

  • Recalled models: F2, F3
  • Total recalled units: 3,721
  • Affected distribution: U.S. and Mexico
  • Stop using devices immediately
  • Contact manufacturer for instructions

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
ELECTRICAL

Product Classification

Product Details

Model Numbers
EDAN Model: F3 UDI-DI code: 06944413800847 Serial/Lot 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 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Affected States
ALL
Report Date
January 28, 2026
Recall Status
ACTIVE

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Fresenius Kabi Vancomycin Injection Recalled Over Sterility Concerns

Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.

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HIGH

Fresenius Kabi Compounding Issues Recall of Vancomycin Injection

Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.

Fresenius Kabi Compounding
Lack of
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HIGH

Pro Numb Tattoo Numbing Spray Recalled Due to cGMP Violations

Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.

PRO NUMB SENSITIVE SKIN
cGMP deviations
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