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

2,247 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 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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Philips Medical Systems Recalls Allura Xper FD10C Over Battery Risk

Philips Medical Systems Nederland B.V. recalled the Allura Xper FD10C model on September 3, 2025, due to a potential BIOS battery issue. The battery may deplete faster than expected, halting system startup without warning. Only two units are affected in the U.S.

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

New Spirit Naturals Recalls Gluta Plus Capsules Over Milk Allergen

New Spirit Naturals recalled 83 units of Gluta Plus (Glutathione) on September 3, 2025, due to undeclared milk allergens. The recall affects specific lot codes and poses a high risk to consumers with milk allergies. This recall is active, and consumers should stop using the product immediately.

New Spirit Naturals
undeclared allergen
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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 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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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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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 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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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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HIGHFDA DEVICE

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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HIGHFDA DEVICE

ImaCor Recalls Miniaturized TEE Probe Due to Assembly Error

ImaCor recalled 45 units of the ClariTEE Miniaturized TEE probe on August 29, 2025, due to a production assembly error. The defect may cause the probe to articulate incorrectly, posing a risk to patient safety. Healthcare providers and patients must stop using the device immediately.

ImaCor
Production assembly
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Northeast Scientific Recalls Laser Atherectomy Catheters Over Sterility Risk

Northeast Scientific recalled 173 units of the R-414-151 laser atherectomy catheter on August 29, 2025. The recall stems from potential breaches in the sterile packaging, which could compromise sterility assurance. Healthcare providers and patients must stop using the device immediately and follow recall instructions.

Northeast Scientific
Potential for
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Northeast Scientific Catheter Recalled Due to Sterility Risk

Northeast Scientific recalled 616 units of its Turbo Elite Laser Atherectomy Catheter on August 29, 2025. The recall affects model R-417-156 due to potential breaches in the sterile barrier packaging. This issue compromises sterility assurance, posing a high risk to patients.

Northeast Scientific
Potential for
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Northeast Scientific Recalls Laser Atherectomy Catheter Over Sterility Risk

Northeast Scientific recalled 1,019 units of the 1.4mm RX Turbo Elite Laser Atherectomy Catheter on August 29, 2025. The recall follows concerns about potential breaches in the sterile barrier packaging. The product poses a high hazard level due to compromised sterility assurance.

Northeast Scientific
Potential for
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Baxter Healthcare Recalls IV Infusion Sets Due to Leak Risk

Baxter Healthcare recalled 27,072 IV infusion sets on August 29, 2025, due to potential leaks. The affected product, model code 2R8858, may pose significant risks to patients. Healthcare providers and patients should stop using these devices immediately.

Baxter Healthcare
IV sets
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HIGHFDA DEVICE

ConvaTec Recalls DuoDERM Dressings Over Foreign Matter Hazard

ConvaTec recalled 80,980 DuoDERM Extra Thin dressings on August 29, 2025, due to potential foreign matter contamination. The dressing is designed for dry to lightly exudating wounds and is suitable for use on sensitive areas. Patients should stop using the product immediately and follow the recall instructions provided by the manufacturer.

ConvaTec
Wound dressing
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Baxter Healthcare Recalls IV Extension Sets Due to Leakage Risk

Baxter Healthcare recalled 2,304 Clearlink System Extension Sets on August 29, 2025, due to potential leakage. The recall affects IV sets distributed nationwide across multiple states. Healthcare providers and patients should stop using the device immediately.

Baxter Healthcare
IV sets
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