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

3,615 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
Health & Personal Care
HIGH
FDA DEVICE

Cook Medical Recalls Transjugular Liver Access Set Over Hazardous Manufacturing

Cook Medical recalled 23 units of its Transjugular Liver Access Sets on November 26, 2025. The recall follows concerns that products may have been manufactured out of specification, leading to potential use errors. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

Cook
Cook Medical
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter Recalls 6,457 Immunoassay Analyzers Over Restart Issues

Beckman Coulter recalled 6,457 UniCel Dxl 800 analyzers on November 26, 2025, due to potential restart failures. The defect prevents the devices from transitioning to Ready mode, delaying patient sample processing. Healthcare providers must stop using the devices immediately and follow recall instructions.

Beckman Coulter
Beckman Coulter
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls IV Administration Kits Over Valve Malfunction Risk

Medline Industries recalled 11,173 IV administration kits on November 26, 2025. The kits contain B. Braun IV Administration Sets and Pump Administration Sets with faulty check valves. These valves may become stuck, posing a high hazard to patients.

Medline Industries, LP
Medline kits
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls IV Administration Sets Due to Valve Issues

Medline Industries recalled 5,314 IV Administration Sets on November 26, 2025. The recall affects several product SKUs due to potential failure of check valve components. Patients and healthcare providers should stop using these devices immediately.

Medline Industries, LP
Medline kits
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Health & Personal Care
HIGH
FDA DRUG

Taro Pharmaceuticals Recalls Clindamycin Phosphate Over Impurities

Taro Pharmaceuticals recalled Clindamycin Phosphate USP, 1% topical solution on November 26, 2025. The recall affects specific lots due to failed impurity testing. Consumers should stop using the product immediately and consult healthcare providers.

CLINDAMYCIN PHOSPHATE
Failed Impurities/Degradation:
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls IV Administration Sets Over Hazardous Check Valves

Medline Industries recalled 633 units of IV administration sets on November 26, 2025. The recall follows complaints that check valve components may become stuck, posing a high risk to patient safety. Healthcare providers and patients must stop using affected products immediately.

Medline Industries, LP
Medline kits
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Health & Personal Care
HIGH
FDA DEVICE

Ferndale Laboratories Recalls Mastisol Liquid Adhesive Over Hazard

Ferndale Laboratories recalled 24,589 vials of Mastisol Liquid Adhesive due to a defect. The butyrate tube may crack during use, making the product unusable. The recall affects products distributed in the U.S. and the U.K., announced on November 25, 2025.

Ferndale Laboratories
Butyrate tube
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Food & Beverages
HIGH
FDA FOOD

Prairie Farms Milk Recalled Due to Food-Grade Cleaning Agents

Prairie Farms Dairy recalled 3,752 gallons of Fat Free Milk on November 25, 2025. The milk may contain food-grade cleaning agents, posing a health risk. Consumers should not consume the product and seek refunds or replacements.

Prairie Farms Dairy
Product may
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Food & Beverages
HIGH
FDA FOOD

Imu-Tek Colostrum Powder Recalled Due to Undeclared Allergen

Imu-Tek Animal Health recalled 113 bottles of Immuno-5 Colostrum Powder on November 25, 2025. The product contains an undeclared milk allergen, posing a risk to consumers with milk allergies. The recall affects states including CA, TX, and FL.

Imu-Tek Animal Health
Undeclared milk
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Health & Personal Care
HIGH
FDA DRUG

Breckenridge Recalls Duloxetine Capsules Over Chemical Hazard

Breckenridge Pharmaceutical, Inc. recalled 7,389 bottles of Duloxetine Delayed-Release Capsules on November 24, 2025. The recall stems from CGMP deviations and the presence of N-nitroso-duloxetine impurity above FDA limits. Consumers should stop using the product immediately and contact healthcare providers for guidance.

DULOXETINE
CGMP Deviations;
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Health & Personal Care
HIGH
FDA DRUG

Duloxetine Capsules Recalled Over High N-Nitroso Impurity Risk

Towa Pharmaceuticals recalled 3,397 bottles of Duloxetine Delayed-Release Capsules on November 24, 2025. The recall stems from CGMP deviations resulting in N-nitroso-duloxetine levels exceeding FDA limits. Consumers must stop using the product immediately.

DULOXETINE
CGMP Deviations;
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Health & Personal Care
HIGH
FDA DEVICE

Abbott Diabetes Care Recalls FreeStyle Libre 3 Sensor Over Glucose Reading Errors

Abbott Diabetes Care recalled over 1 million FreeStyle Libre 3 sensors on November 24, 2025, due to a manufacturing issue. The defect may lead to incorrect low glucose readings, posing a serious health risk. Affected sensors were distributed across the U.S. and several international markets.

Abbott Diabetes Care
Due to
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Food & Beverages
HIGH
FDA FOOD

Gimme Coffee Recalls Pods Over Undeclared Caffeine Hazard

Gimme Coffee, Inc. recalled 252 boxes of Decaf de Agua coffee pods on November 24, 2025. The product contains undeclared caffeine, posing a risk to consumers sensitive to caffeine. Affected products include those with best-by dates of September 30, 2025, and October 15, 2025.

Gimme Coffee
Undeclared caffeine
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Food & Beverages
HIGH
FDA FOOD

Bell Industries Recalls Zen Cleanse Blend Tea for Salmonella Risk

Bell Industries recalled 66 units of Zen Cleanse Blend herbal tea on November 24, 2025. The recall follows potential Salmonella contamination. The product was distributed to three customers in Massachusetts, Texas, and Wisconsin, but did not reach retail shelves.

Bell Industries
Potential Salmonella
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Health & Personal Care
HIGH
FDA DEVICE

Draeger Vapor 3000 Anesthetic Vaporizer Recalled Due to Impurities

Draeger, Inc. recalled 188 units of the Vapor 3000 anesthetic vaporizer on November 24, 2025. The devices contained impurities in a component not delivered within specification. Healthcare providers and patients must stop using the devices immediately.

Draeger
A certain
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Health & Personal Care
HIGH
FDA DEVICE

Draeger Vapor 2000 Anesthetic Vaporizer Recalled Over Impurities

Draeger, Inc. recalled 431 units of the Vapor 2000 anesthetic vaporizer on November 24, 2025. A component of the devices contained impurities and did not meet specifications, posing a high hazard risk. Healthcare providers and patients should cease use immediately and follow recall instructions.

Draeger
A certain
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Health & Personal Care
HIGH
FDA DEVICE

ICU Medical Recalls LifeShield Infusion Software Over Delivery Risk

ICU Medical recalled the LifeShield Infusion Safety Software Suite v2.2 on November 24, 2025. The software fails to operate as expected for migrated libraries, risking medication delivery errors. The recall affects seven customers across several states, including California and New York.

ICU Medical
For certain
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Health & Personal Care
HIGH
FDA DEVICE

ICU Medical Recalls LifeShield Infusion Safety Software Due to Risk

ICU Medical recalled LifeShield Drug Library Management software on November 24, 2025. A software issue limits concentration precision to one decimal place, risking incorrect drug dosages. Users should stop using the product immediately and follow recall instructions.

ICU Medical
Software issue
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Health & Personal Care
HIGH
FDA DEVICE

Abbott Recalls FreeStyle Libre 3 Plus Sensors Due to Hazardous Readings

Abbott Diabetes Care recalled 258,913 FreeStyle Libre 3 Plus sensors on November 24, 2025. Manufacturing issues may lead to incorrect low glucose results, posing a high risk to users. Consumers should stop using the device immediately and follow the recall instructions.

Abbott Diabetes Care
Due to
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