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.

High Risk Recalls

2,251 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

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
HIGHFDA DEVICE

Medline Recalls CURAD Germ-Shield Bandages Over Sterility Risk

Medline Industries recalled 182,526 units of CURAD Germ-Shield Touch-Free Fabric Bandages due to compromised sterility. The recall affects all lots manufactured and distributed in the US, Guam, Canada, and the UAE. Consumers must stop using these bandages immediately.

Medline Industries, LP
Medline has
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HIGHFDA DEVICE

Philips Recalls Azurion 7 M20 X-ray System Over Safety Concern

Philips North America recalled 110 Azurion 7 M20 interventional fluoroscopic X-ray systems on October 27, 2025. These devices were shipped without the necessary Source-to-Skin Distance (SSD) Spacer, violating FDA regulations. The absence of this spacer poses a serious health risk during fluoroscopy applications.

Philips North America
Between July
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HIGHFDA DRUG

Cipla USA Recalls Lanthanum Carbonate Tablets Over Stability Issues

Cipla USA recalled 1,180 boxes of Lanthanum Carbonate chewable tablets on October 24, 2025. The recall follows a failure to meet stability specifications for hardness tests. Consumers and healthcare providers must stop using the product immediately.

LANTHANUM CARBONATE
Failed stability
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HIGHFDA DEVICE

Siemens Medical Solutions Recalls MAMMOMAT Fusion Operator Table

Siemens Medical Solutions USA recalled one MAMMOMAT Fusion operator table on October 24, 2025. The table was sold with a bus-installation kit but is intended for stationary use only. This recall affects distribution in Arkansas, California, New York, and internationally in Australia, Canada, and India.

Siemens Medical Solutions USA
There were
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HIGHFDA DEVICE

Siemens Recalls MAMMOMAT Inspiration Operator Tables Due to Hazard

Siemens Medical Solutions USA recalled six MAMMOMAT Inspiration operator tables on October 24, 2025. The operator tables were sold with a bus-installation kit, which they are not designed for. This recall affects three units in the U.S. and three internationally.

Siemens Medical Solutions USA
There were
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HIGHFDA DEVICE

EDAN Recalls Central Monitoring System Due to Cybersecurity Risk

EDAN recalled 195 units of its Central Monitoring System MFM-CMS on October 24, 2025, due to potential cybersecurity issues. The recall follows an FDA letter warning about vulnerabilities that could impact device functionality. Users must stop using the device immediately and follow the manufacturer’s instructions for a remedy.

Edan Diagnostics
As a
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HIGHFDA DEVICE

EDAN Recalls Vital Signs Monitors Due to Cybersecurity Risks

EDAN recalled 136 vital signs monitors on October 24, 2025, due to potential cybersecurity issues. The devices include models iM3s, iM3As, iM3Bs, and iHM3s. Patients and healthcare providers must stop using these monitors immediately and follow recall instructions.

Edan Diagnostics
As a
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HIGHFDA DEVICE

EDAN Central Monitoring System Recalled Over Cybersecurity Issues

EDAN recalled 395 units of its Central Monitoring System on October 24, 2025, due to potential cybersecurity risks. The affected models include MFM-CNS and MFM-CNS Lite, which manage critical fetal and maternal health data. Healthcare providers must stop using the devices immediately and follow the recall instructions.

Edan Diagnostics
As a
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HIGHFDA DEVICE

EDAN Recalls Patient Monitors Due to Cybersecurity Risks

EDAN recalled 3,141 patient monitors on October 24, 2025, due to potential cybersecurity vulnerabilities. The recall affects models iM8, iM8A, and iM8B used for monitoring physiological parameters. Healthcare providers must stop using these devices immediately and follow the manufacturer's instructions.

Edan Diagnostics
As a
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HIGHFDA DEVICE

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.

Edan Diagnostics
As a
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HIGHFDA FOOD

MeriCal Recalls Super Greens Supplement Due to Salmonella Risk

MeriCal, LLC recalled 698,064 units of its Super Greens Dietary Supplement on October 24, 2025. The recall follows potential contamination with Salmonella Richmond. Consumers should not consume the product and seek refunds immediately.

MeriCal
Potential contamination
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HIGHFDA 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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HIGHFDA DEVICE

EDAN Vital Signs Monitor Recalled Over Cybersecurity Issues

EDAN recalled 13,934 M3 Vital Signs Monitors on October 24, 2025 due to potential cybersecurity issues. The recall affects devices distributed in multiple U.S. states and Mexico. Healthcare professionals must stop using the device immediately and follow manufacturer instructions.

Edan Diagnostics
As a
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HIGHFDA DEVICE

EDAN Recalls Vital Signs Monitor Due to Cybersecurity Issues

EDAN recalled 12,201 Vital Signs Monitors on October 24, 2025, due to potential cybersecurity vulnerabilities. The affected M3A model poses a high risk to patient safety by compromising monitoring accuracy. Users must stop using the devices immediately and follow recall instructions.

Edan Diagnostics
As a
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HIGHFDA DEVICE

EDAN Telemetry Transmitter Recalled Over Cybersecurity Concerns

EDAN recalled 1,457 iT20 telemetry transmitters on October 24, 2025, due to potential cybersecurity issues. The recall affects devices distributed in the United States and Mexico. Healthcare providers and patients must immediately discontinue use of the device.

Edan Diagnostics
As a
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