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

IMRIS Imaging Recalls Head Fixation Device Over Safety Concerns

IMRIS Imaging recalled 122 Head Fixation Devices on December 8, 2025. A torque screw may crack or separate, posing serious risks during surgical procedures. Healthcare providers must stop using the device and follow recall instructions immediately.

IMRIS Imaging
Torque screw
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HIGHFDA DRUG

ORL Kids Toothpaste Recalled Due to cGMP Deviations

ORL Labs recalled 1,458 containers of ORL Kids Natural Toothpaste, Bubblegum Flavor, on December 8, 2025. The recall follows cGMP deviations that could pose health risks. Consumers should stop using the product immediately.

ORL Labs
cGMP Deviations
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HIGHFDA DEVICE

Beckman Coulter Recalls LDL Cholesterol Assay Due to Performance Issues

Beckman Coulter recalled 34,451 units of its LDL Cholesterol OSR6x96 assay on December 8, 2025, due to significant performance interference. The recall affects multiple states in the U.S. and several countries internationally. Affected products may provide inaccurate LDL cholesterol readings, posing health risks to patients.

Beckman Coulter Ireland
Beckman Coulter
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HIGHFDA DRUG

ORL Labs Recalls Kids Mouthwash Over cGMP Deviations

ORL Labs, LLC recalled 570 bottles of ORL Kids Mouthwash, Bubblegum Flavor on December 8, 2025. The recall stems from violations of current Good Manufacturing Practices (cGMP). The product was distributed only in Arizona and poses potential safety risks for children.

ORL Labs
cGMP Deviations
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HIGHFDA FOOD

Sam Dry Fruits Pistachio Meats Recalled Due to Salmonella Risk

Sam Dry Fruits & Nuts Enterprises recalled 32,610 pounds of pistachio meats on December 8, 2025. The recall stems from potential Salmonella contamination. Consumers should not consume the product and seek a refund.

Sam Dry Fruits and Nuts Enterprises
Potential contamination
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HIGHFDA DEVICE

Philips Azurion Systems Recalled Due to Software Issues

Philips recalled 990 Azurion Systems on December 8, 2025, after nine software issues were identified. The defects may cause loss of X-ray functionality, system restarts, and other operational failures. Healthcare providers must stop using the devices immediately.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Nine (9)
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HIGHFDA FOOD

Goldenroot Ginger Beer Recalled for Pasteurization Failure

Goldenroot recalled 1,070 cases of Lemon Double Ginger Beer on December 8, 2025. The ginger beer may contain unpasteurized ginger juice, posing a health risk. Consumers should not consume the product and seek refunds immediately.

Weaver's Brew
Ginger Beer
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HIGHFDA FOOD

Weaver's Brew Ginger Beer Recalled Over Pasteurization Issues

Weaver's Brew recalled 1,014 cases of Lemon Ginger Hibiscus Ginger Beer on December 8, 2025. The product might contain unpasteurized ginger juice, posing a high health risk. Consumers should not consume the product and should seek refunds.

Weaver's Brew
Ginger Beer
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HIGHFDA FOOD

Goldenroot Ginger Beer Recalled Over Pasteurization Issues

Goldenroot recalled 1,066 cases of Lemon Ginger Elderberry Ginger Beer on December 8, 2025. The product may contain unpasteurized ginger juice, posing a health risk. Consumers should stop using the product immediately and seek a refund or replacement.

Weaver's Brew
Ginger Beer
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HIGHFDA FOOD

Goldenroot Ginger Beer Recalled Over Pasteurization Issues

Goldenroot recalled 649 cases of Yuzu Ginger Lemongrass Ginger Beer on December 8, 2025. The product may contain ginger juice that did not undergo required pasteurization. Consumers should not consume it and seek refunds from Weaver's Brew LLC.

Weaver's Brew
Ginger Beer
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HIGHFDA FOOD

Goldenroot Ginger Beer Recalled Over Pasteurization Issue

Goldenroot recalled 421 cases of Lemon Ginger Jalapeno Ginger Beer on December 8, 2025. The recall stems from potential unpasteurized ginger juice, posing a health risk. Consumers should not consume the product and seek refunds immediately.

Weaver's Brew
Ginger Beer
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HIGHNHTSA

Honda Pilot Recalled for Brake Pedal Issue Increasing Crash Risk

Honda recalled certain 2021-2025 Acura TLX, 2023-2025 Acura MDX, and 2023-2025 Honda Pilot vehicles due to a brake pedal defect. The brake pedal pivot pin may not be secured properly, increasing the risk of a crash. Owner notification letters were mailed on July 29, 2025.

Honda
A brake
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HIGHFDA FOOD

Keurig Recalls McCafe Decaf Coffee Pods Due to Caffeine Risk

Keurig Green Mountain recalled 960 cartons of McCafe Premium Roast Decaf Coffee K-Cup Pods on December 6, 2025. The product is inaccurately labeled as decaf but may contain caffeine. Consumers in CA, IN, and NV should not consume the pods and seek refunds.

Keurig DR Pepper
Product is
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