These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

Immediate attention

High Risk Recalls

3,598 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.
High-risk recalls
3,598
Action level
Stop use

What to do if you own a recalled product

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
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
As a
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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
As a
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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
As a
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Health & Personal Care
HIGH
FDA DEVICE

GE Medical Systems Recalls Mammography Systems Over Labeling Hazard

GE Medical Systems recalled 1,818 Senographe Pristina mammography systems on October 24, 2025. The recall affects systems due to missing or incorrect X-Ray Warning labels. This nonconformance to FDA regulations poses a high hazard risk.

GE Medical Systems
Some Senographe
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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
As a
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