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

Fujirebio Diagnostics Recalls Diagnostic Test Over Inaccurate Results

Fujirebio Diagnostics recalled 23 units of its Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio test on December 11, 2025. The recall follows concerns that the product may produce inaccurate test results, potentially misclassifying patients with Alzheimer's disease. Healthcare providers should stop using this device immediately and follow recall instructions.

Fujirebio Diagnostics
Customers may
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HIGHFDA DEVICE

Fujirebio Diagnostics Recalls Plasma Calibrators Over Inaccurate Results

Fujirebio Diagnostics recalled 128 units of Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators on December 11, 2025. The recall stems from the risk of inaccurate test results leading to misclassification of Alzheimer’s disease. Affected products may cause patients to receive unnecessary additional clinical testing.

Fujirebio Diagnostics
Customers may
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HIGHFDA DEVICE

Fujirebio Diagnostics Recalled pTau 217 Plasma Cartridges

Fujirebio Diagnostics recalled 1,569 units of Lumipulse G pTau 217 Plasma Immunoreaction Cartridges on December 11, 2025. The recall affects users due to potential inaccurate test results associated with Alzheimer's disease classifications. Customers in 13 states should stop using the product immediately.

Fujirebio Diagnostics
Customers may
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HIGHFDA DEVICE

Fujirebio Diagnostics Recalls Lumipulse pTau 217 Plasma Controls Due to High Risk of Inaccurate Test

Fujirebio Diagnostics recalled 148 units of Lumipulse pTau 217 Plasma Controls on December 11, 2025. The recall follows reports of inaccurate test results that misclassify patients regarding Alzheimer’s disease. The affected product may falsely elevate positive or indeterminate results, increasing the risk of incorrect patient classification.

Fujirebio Diagnostics
Customers may
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HIGHFDA DEVICE

Fujirebio Diagnostics Recalls Lumipulse G pTau 217 Plasma Calibrators

Fujirebio Diagnostics has recalled 117 units of Lumipulse G pTau 217 Plasma Calibrators due to inaccurate test results. The recall was announced on December 11, 2025, after customers reported false classifications of Alzheimer’s disease. Affected products were distributed nationwide, including in states like California and Florida.

Fujirebio Diagnostics
Customers may
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HIGHFDA DEVICE

GE HealthCare Recalls Nuclear Medicine Systems Over Fall Risk

GE HealthCare recalled 38 Nuclear Medicine systems on December 10, 2025, due to potential detector falls. The affected systems may have been relocated without adequate support, risking serious injury. No incidents have been reported, but the recall is classified as a Class II hazard.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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HIGHFDA FOOD

White Castle Original Sliders Recalled Due to Undeclared Allergens

White Castle recalled 1,021 cases of Original Sliders on December 10, 2025. The product contains undeclared milk and soy allergens, posing a high risk to consumers. The affected lot codes are 9H203521 and 9H203522, with a Best By date of April 18, 2026.

White Castle System
Undeclared allergens
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HIGHFDA FOOD

Publix Coffee Cake Recalled Due to Undeclared Walnuts

Publix recalled 811 cases of Raspberry Coffee Cake on December 10, 2025. The product contains undeclared walnuts, posing a serious allergen risk. Consumers should not consume the product and seek a refund.

The James Skinner
Undeclared allergen
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HIGHFDA DEVICE

GE HealthCare Recalls Nuclear Medicine Systems Over Fall Risk

GE HealthCare recalled three Nuclear Medicine systems on December 10, 2025. The recall follows concerns over inadequate detector support, which could lead to a fall and serious injury. No incidents have been reported to date.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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HIGHFDA DEVICE

REPLIGEN Spectrometer Recalled Due to Laser Hazard

REPLIGEN Corporation recalled 33 Maverick Measurement Module Spectrometers on December 10, 2025. Disconnected or poorly crimped cables may cause elevated laser output or unintended firing. The recall affects devices distributed in the U.S.

REPLIGEN
Potential Elevated
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HIGHFDA DEVICE

GE HealthCare Recalls Nuclear Medicine Systems Due to Fall Risk

GE HealthCare recalled 12 Nuclear Medicine systems on December 10, 2025, due to a potential fall hazard. The affected systems may have inadequate support during transport, risking detector integrity. No injuries have been reported, but the risk of life-threatening incidents exists.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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HIGHFDA DEVICE

Elekta Recalls MOSAIQ Oncology System Over Overtreatment Risk

Elekta recalled the MOSAIQ Oncology Information System on December 10, 2025. A malfunction may cause overtreatment in patients due to software issues. Healthcare providers should stop using the device immediately and follow recall instructions.

Elekta
Using oncology
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HIGHFDA DEVICE

GE Healthcare Recalls Nuclear Medicine Systems Due to Fall Hazard

GE Healthcare recalled seven Nuclear Medicine systems on December 10, 2025, due to potential detector falls. The recall affects systems that have exceeded their End of Guaranteed Service. No injuries or falls have been reported.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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HIGHFDA DEVICE

Mazor Robotics Recalls Robotic Guidance System Over Software Errors

Mazor Robotics recalled 549 Mazor X robotic guidance systems on December 10, 2025, due to software errors. These errors may cause incorrect surgical instrument positioning during spinal surgeries. Patients and healthcare providers must stop using the device immediately.

Mazor Robotics
Software errors
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HIGHNHTSA

Hyundai IONIQ 5 Recalled for Suspension Fastener Issues

Hyundai Motor America recalled certain 2025 IONIQ 5 electric vehicles due to improperly tightened rear suspension bolts. This defect may lead to loss of vehicle stability control and increase crash risk. Owners will receive notification letters by November 10, 2025.

Hyundai
A loss
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HIGHNHTSA

Hyundai Recalls 2025 IONIQ 6 Over Charging Port Hazard

Hyundai Motor America recalled certain 2023-2025 IONIQ 6 electric vehicles due to a potential detachment of the charging port door panel. The recall affects vehicles sold until November 2025. A detached panel poses a road hazard, increasing crash risk.

Hyundai
A detached
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HIGHFDA DEVICE

Heraeus Medical Recalls PALACOS Bone Cement Due to Breakage Risk

Heraeus Medical GmbH recalled PALACOS MV+G pro 40 and MV+G pro 80 bone cement on December 9, 2025. The recall follows complaints about ampoule breakage, which can prevent proper cement formation. This issue could jeopardize patient safety during medical procedures.

Heraeus Medical GmbH
increase of
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