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

1,488 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

Philips Medical Systems Recalls Allura Xper FD20 Biplane Due to Battery Risk

Philips Medical Systems recalled 501 Allura Xper FD20 Biplane systems on September 3, 2025. The BIOS battery may deplete quickly, halting system startup without warning. The recall affects devices distributed worldwide, including the US and several countries in Europe and Asia.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The BIOS
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Philips Medical Systems Recalls Operating Room Tables Over Battery Issue

Philips Medical Systems recalled 298 Allura Xper FD20 operating room tables on September 3, 2025, due to a faulty BIOS battery. The battery depletes faster than expected, halting system start-up without warning. This recall affects 72 units in the U.S. and 226 units distributed internationally.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The BIOS
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HIGHFDA DRUG

Glenmark Pharmaceuticals Recalls Viorele Tablets Over Impurity Issues

Glenmark Pharmaceuticals recalled 26,928 packs of Viorele oral contraceptives on September 3, 2025. The recall follows the discovery of impurity issues in the product. Consumers should stop using the affected tablets immediately and contact healthcare providers for guidance.

Viorele
Failed Impurities/Degradation
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HIGHFDA FOOD

New Spirit Naturals Recalls Muscle Support Powder Due to Milk Allergen

New Spirit Naturals recalled 178 units of Super Muscle Support Powder on September 3, 2025. The product contains an undeclared allergen, milk, posing a serious health risk. Consumers should stop using the product immediately and contact the company for a refund.

New Spirit Naturals
undeclared allergen
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HIGHFDA DRUG

Cardinal Health Recalls Sulfamethoxazole and Trimethoprim Over Microbial Risk

Cardinal Health recalled Sulfamethoxazole and Trimethoprim tablets on September 2, 2025, due to contamination risks. A specific lot contained a foreign substance with a detected micro-organism, although no contamination was found on the tablets. Consumers must stop using the product immediately and seek guidance from healthcare providers.

SULFAMETHOXAZOLE AND TRIMETHOPRIM
Presence of
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HIGHFDA DRUG

Major Pharmaceuticals Recalls Prescription Medication Over Contamination Risk

Major Pharmaceuticals recalled Sulfamethoxazole and Trimethoprim tablets on September 2, 2025, due to contamination concerns. A foreign substance was found in the packaging material, although the tablets themselves remain unaffected. Consumers should stop using the product immediately and consult healthcare providers.

SULFAMETHOXAZOLE AND TRIMETHOPRIM
Presence of
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LeMaitre Vascular Recalls Collagen Vascular Grafts Over Sourcing Issue

LeMaitre Vascular recalled 28 units of Artegraft Collagen Vascular Grafts on September 2, 2025. The recall affects multiple model numbers due to unapproved sourcing of raw materials. Patients and healthcare providers must stop using the device immediately and follow recall instructions.

LeMaitre Vascular
The bovine
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HIGHFDA FOOD

I C F Factory Recalls Ice Cream Due to Undeclared Almonds

I C F Factory recalled Vanilla G. Nutt Ice Cream on August 29, 2025, due to undeclared almonds. The recall affects 12 pints distributed in New York. Consumers should not consume the product and should seek a refund.

I C F Factory
May contained
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BigTree Sales Recalls UVC Germicidal Wand Over Radiation Risk

BigTree Sales Inc. recalled a handheld ultraviolet-C germicidal wand on August 29, 2025, due to unsafe levels of UVC radiation. The product can cause skin and eye injuries to users and nearby individuals. Consumers must stop using the device immediately and follow the manufacturer's instructions.

BigTree Sales
The subject
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HIGHFDA DRUG

Fagron Compounds Recalls Bevacizumab Injection Over Sterility Risk

Fagron Compounding Services recalled 109,320 syringes of bevacizumab (Avastin) on August 29, 2025. The recall follows a lack of assurance of sterility, posing a high health risk. Consumers and healthcare providers should stop using the product immediately.

Fagron Compounding Services
Lack of
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Baxter Healthcare Recalls IV Sets Due to Leak Risk

Baxter Healthcare recalled 136,512 IV sets on August 29, 2025, due to potential leaks. The recall affects products distributed nationwide across the United States. Patients and healthcare providers must stop using these devices immediately.

Baxter Healthcare
IV sets
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Baxter Healthcare Recalls IV Sets Due to Leakage Risk

Baxter Healthcare recalled 12,720 CONTINU-FLO Solution Sets on August 29, 2025, due to a risk of leakage. The recall affects various states across the U.S. Healthcare providers and patients must stop using the product immediately.

Baxter Healthcare
IV sets
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Baxter Healthcare Recalls IV Sets Due to Leakage Risk

Baxter Healthcare recalled 18,720 IV solution sets on August 29, 2025, due to a leak hazard. The recall affects devices distributed across the United States, including all 50 states. Patients and healthcare providers should stop using these devices immediately.

Baxter Healthcare
IV sets
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Baxter Healthcare Recalls IV Extension Sets Over Leak Risk

Baxter Healthcare recalled 15,552 IV extension sets on August 29, 2025, due to a leak risk. The recall affects products distributed nationwide across 50 states. Healthcare providers and patients must stop using the devices immediately.

Baxter Healthcare
IV sets
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Baxter Healthcare Recalls IV Extension Sets Due to Leak Risk

Baxter Healthcare recalled 69,936 IV extension sets on August 29, 2025, due to a risk of leaking. The recall affects products with the code 2H8603 distributed nationwide. Patients and healthcare providers must stop using these devices immediately.

Baxter Healthcare
IV sets
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Baxter Healthcare Recalls IV Solution Set Due to Leakage Risk

Baxter Healthcare recalled 106,176 units of the CLEARLINK SYSTEM CONTINU-FLO Solution Set on August 29, 2025. The recall follows reports that the IV sets may leak, posing a high risk to patients. Healthcare providers and patients must stop using the device immediately.

Baxter Healthcare
IV sets
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