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

783 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 Cardiac Monitor Over Battery Issue

Philips Medical Systems recalled 313 cardiac monitors on September 3, 2025, due to a BIOS battery issue. The battery may deplete unexpectedly, halting the device's start-up process without warning. Patients and healthcare providers must stop using the device immediately.

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

Inpeco S.A. Recalls Potassium Test System Over Safety Concerns

Inpeco S.A. recalled eight units of its FlexLab (FLX) Potassium Test System on September 3, 2025. The system's Sample Integrity Module may produce erroneous results due to unverified functions. Healthcare providers must stop using the device immediately and follow the manufacturer's instructions.

Inpeco S.A.
The FlexLab
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HIGHFDA DEVICE

Beckman Coulter Reagents Recalled Due to Calibration Failure

Beckman Coulter recalled 2,146 units of SYNCHRON Systems Phosphorus reagents on September 3, 2025. The affected lots may fail calibration before expiration, delaying patient results. Healthcare providers must stop using the product immediately.

Beckman Coulter
Specific SYNCHRON
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HIGHFDA DEVICE

Philips Medical Systems Recalls Operating Room Table Over Battery Issue

Philips Medical Systems Nederland B.V. recalled the Allura Xper FD10 Operating Room Table on September 3, 2025. The BIOS battery may deplete faster than expected, halting the system's start-up process. This recall affects two units distributed worldwide, including the U.S. and multiple countries.

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

Philips Medical Systems Recalls Allura Xper FD20/10 Over Battery Issue

Philips Medical Systems Nederland B.V. recalled 87 Allura Xper FD20/10 medical imaging devices on September 3, 2025. The BIOS battery may deplete faster than expected, halting the system's start-up process without warning. Healthcare providers and patients should stop using these devices immediately.

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

Philips Medical Systems Recalls Allura Xper FD20 Due to Battery Hazard

Philips Medical Systems Nederland B.V. recalled 5,067 Allura Xper FD20 devices on September 3, 2025. The BIOS battery may deplete unexpectedly, halting the system's start-up process. This issue affects models 722006, 722012, and 722028 and poses a high risk to patient safety.

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

Philips Medical Systems Recalls Allura Xper CV20 Over Battery Issue

Philips Medical Systems Nederland B.V. recalled 53 Allura Xper CV20 medical imaging systems on September 3, 2025. The BIOS battery may deplete faster than anticipated, halting the system's start-up process. Users will not receive warnings before the battery depletes.

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

Philips Medical Systems Recalls Operating Room Table Over Battery Issue

Philips Medical Systems Nederland B.V. recalled the Allura Xper FD20/20 operating room table on September 3, 2025, due to a potential BIOS battery failure. The battery may deplete faster than expected, causing the system to halt without warning. This recall affects five units distributed worldwide.

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

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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