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Edan Diagnostics Recalls

16 recalls found for Edan Diagnostics. Check current safety alerts and related brands before using affected products.
Active recalls
16
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Health & Personal Care
HIGH
FDA DEVICE

EDAN Patient Monitors Recalled Due to Cybersecurity Risks

EDAN recalled 379 patient monitors on October 24, 2025, due to potential cybersecurity issues. Models iX10, iX12, and iX15 pose risks to patient safety. Healthcare providers should stop using these devices immediately.

Edan Diagnostics
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Health & Personal Care
HIGH
FDA DEVICE

EDAN Patient Monitors Recalled Over Cybersecurity Issues

EDAN recalled 3,824 Patient Monitors on October 24, 2025. The recall follows an FDA letter regarding cybersecurity vulnerabilities. Affected models include X8, X10, and X12, distributed nationwide and to Mexico.

Edan Diagnostics
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Health & Personal Care
HIGH
FDA DEVICE

EDAN Recalls iM20 Patient Monitor Over Cybersecurity Risk

EDAN recalled 377 iM20 Patient Monitors on October 24, 2025, due to cybersecurity issues. The recall affects devices distributed nationwide in the U.S. and Mexico. Healthcare providers must stop using this device immediately.

Edan Diagnostics
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Health & Personal Care
HIGH
FDA DEVICE

EDAN Recalls Patient Monitors Due to Cybersecurity Risks

EDAN recalled 342 patient monitors on October 24, 2025, due to potential cybersecurity issues. Models affected include elite V5, elite V6, and elite V8. Healthcare providers and patients should stop using these devices immediately.

Edan Diagnostics
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Health & Personal Care
HIGH
FDA DEVICE

EDAN Recalls Fetal & Maternal Monitors Over Cybersecurity Risks

EDAN recalled 3,518 fetal and maternal monitors on October 24, 2025, due to potential cybersecurity issues. Affected models include F6, F9, F6 Express, and F9 Express. The recall impacts devices distributed in the U.S. and Mexico.

Edan Diagnostics
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