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

456 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 FOOD

DFA Dairy Brands Recalls Friendly's Ice Cream Over Allergen Risk

DFA Dairy Brands recalled 54 cases of Friendly's Ice Cream on August 1, 2025. The product contains undeclared wheat and soy, posing a serious allergen risk. Consumers in Maryland, Virginia, and Pennsylvania should not consume the affected ice cream.

DFA Dairy Brands
Product contains
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Recalled Magnetic Floating Stackers toy, model STA-BGY-801T (Rainbow)
HIGH
CPSC

Tegu Recalls Magnetic Floating Stackers Due to Ingestion Hazard

Tegu recalled its Magnetic Floating Stackers on July 31, 2025, after discovering a magnet ingestion hazard. The recall affects model numbers STA-BGY-801T and STA-BTP-806T. The toys can pose serious injuries or death if magnets detach and are swallowed.

Tegu
The recalled
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HIGHFDA DEVICE

Waldemar Link Recalls LinkSymphoKnee Tibial Component Over Safety Hazard

Waldemar Link GmbH & Co. KG recalled eight units of the LinkSymphoKnee Tibial Component on July 31, 2025. The recall stems from a manufacturing error involving uncoated security screws. Patients and healthcare providers should stop using the device immediately.

Waldemar Link GmbH & Co. KG
Some modular
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Recalled Amazon Basics Premium Foam Eurotop Mattress
HIGH
CPSC

Amazon Recalls Foam Eurotop Mattresses Due to Fire Hazard

Amazon recalled Amazon Basics Premium Foam Eurotop Mattresses on July 31, 2025, due to fire hazards. The mattresses violate federal flammability standards, posing serious risk to consumers. Affected models were sold on Amazon from December 2022 through May 2024.

Amazon
The recalled
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Recalled Baby Loren Children's Joy Loungewear
HIGH
CPSC

Baby Loren Recalls Children's Loungewear Over Burn Hazard

Baby Loren recalled children's loungewear on July 31, 2025, due to serious burn risks. The loungewear violates federal flammability standards, endangering children. Affected items include dresses in various prints and sizes 2T to 6Y.

Baby Loren
The recalled
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HIGHFDA DEVICE

Fortress Introducer Sheath System Recalled Due to Labeling Error

Contract Medical International GmbH recalled 2,500 Fortress Introducer Sheath Systems on July 30, 2025. Units may have incorrect pouch labeling, leading to potential use of the wrong device version. Patients and healthcare providers should stop using the product immediately.

Contract Medical International GmbH
Units may
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HIGHFDA DRUG

Exela Pharma Recalls Sodium Bicarbonate Injection Over Arsenic Risk

Exela Pharma Sciences recalled 4.2% Sodium Bicarbonate Injection on July 30, 2025, due to arsenic contamination. The recall affects single-dose vials distributed nationwide. Consumers and healthcare providers must stop using the product immediately.

SODIUM BICARBONATE
Failed Impurities/Degradation
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HIGHFDA DEVICE

Ortho-Clinical Diagnostics Recalls LAC Slides Over Calibration Failures

Ortho-Clinical Diagnostics recalled 2,908 units of VITROS Chemistry Products LAC Slides on July 29, 2025. The recall affects lots from coating 0130 and above due to increased calibration failures that delay test results. The issue may impact patient management and was identified through an uptick in customer complaints.

Ortho-Clinical Diagnostics
VITROS Chemistry
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HIGHFDA DRUG

Pfizer Recalling Levoxyl Due to Subpotent Drug Hazard

Pfizer Inc. recalled 29,004 bottles of Levoxyl on July 29, 2025, due to subpotency. The recall affects levothyroxine sodium tablets, 50 mcg, Rx only, distributed in the U.S. Consumers should stop using the product immediately.

Levoxyl
Subpotent drug
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HIGHFDA DEVICE

Ortho-Clinical Diagnostics Recalls LAC Slides Due to Calibration Failures

Ortho-Clinical Diagnostics recalled 2,320 units of VITROS Chemistry Products LAC Slides on July 29, 2025. Calibration failures in lots from coating 0130 and above delay test results and may impact patient management. Healthcare providers and patients must stop using these slides immediately.

Ortho-Clinical Diagnostics
VITROS Chemistry
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HIGHFDA DEVICE

ORTOMA Inserter Adapter Recalled Due to Weld Breakage Hazard

ORTOMA AB recalled 261 Inserter Adapters on July 28, 2025, due to a potential weld failure. The defect poses a risk of improper positioning during hip implant procedures. The recall affects devices distributed worldwide, including the U.S. and countries like Japan and Sweden.

ORTOMA AB
Due to
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HIGHFDA DEVICE

Medline Recalls Intubation Trays Due to Light Failure Hazard

Medline Industries, LP recalled 2,520 medical convenience kits on July 25, 2025. The recall affects multiple intubation trays containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles. The light in these devices fails to illuminate, posing a serious risk in emergency situations.

Medline Industries, LP
Medline Industries,
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HIGHFDA DRUG

Duloxetine Capsules Recalled Due to High N-nitroso Impurity

Towa Pharmaceutical Europe recalled 1,856 bottles of Duloxetine delayed-release capsules on July 25, 2025. The recall follows the discovery of N-nitroso-duloxetine impurity exceeding FDA limits. Consumers should stop using the product immediately and seek guidance.

DULOXETINE
CGMP Deviations:
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HIGHFDA DEVICE

Medline Recalls Medical Kits Over Laryngoscope Light Failure

Medline Industries, LP recalled 596 medical convenience kits on July 25, 2025. The recall affects kits with Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to light failure. Patients and healthcare providers must stop using these devices immediately.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Merit Medical Recalls Hemostasis Valve Over Foreign Body Risk

Merit Medical Systems recalled 447 units of the 10Fore Hemostasis Valve on July 25, 2025. A manufacturing issue may cause a deformed silicone quad ring, posing a risk of foreign body in the fluid pathway. This recall affects the U.S. and Canada.

Merit Medical Systems
Due to
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