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 DEVICE

Olympus Recalls ViziShot 2FLEX Needle Over Hazard Risk

Olympus Corporation of the Americas recalled 103,731 units of the ViziShot 2FLEX aspiration needle on August 6, 2025. The recall stems from a risk of undetected, deformed a-traumatic tips that could affect patient safety. The product is distributed worldwide, including the US, Australia, and Germany.

Olympus Corporation of the Americas
Potential for
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HIGHFDA DEVICE

Boston Scientific NephroMax Kit Recalled Over Foreign Material Risk

Boston Scientific recalled 458 NephroMax Kits on August 5, 2025, due to contamination risk. The Encore 26 Inflation Device may allow foreign particles to enter balloon dilatation catheters. Patients must stop using the device immediately and follow recall instructions.

Boston Scientific
The Encore
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HIGHFDA DRUG

Sandoz Recalls Enoxaparin Sodium Injection Due to Mislabeling

Sandoz Inc. recalled 10 bags of Enoxaparin Sodium Injection on August 5, 2025. Bags labeled for Enoxaparin Sodium 80 mg/0.8 mL contained the incorrect dosage of 30 mg/0.3 mL. Consumers and healthcare providers must stop using the product immediately.

ENOXAPARIN SODIUM
Correct Labeled
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HIGHFDA DEVICE

Philips Medical Systems Recalls Radiation Therapy Planning Software

Philips Medical Systems recalled 810 units of its Radiation Therapy Planning System on August 5, 2025. A software issue may cause image errors during treatment planning. Affected models include Pinnacle TumorLOC and Multimodality Simulation Workspace.

Philips Medical Systems
Due to
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HIGHFDA DRUG

Haleon US Holdings Recalls Sensodyne Toothpaste Due to Label Mix-Up

Haleon US Holdings recalled 46,692 tubes of Sensodyne PRONAMEL toothpaste on August 5, 2025, due to a labeling mix-up. The outer carton states Fresh Mint while the tube claims Cool Mint/Whitening. The actual product inside is Fresh Mint, leading to potential consumer confusion.

Haleon US Holdings
Labeling: Label
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HIGHFDA FOOD

Neuhaus Chocolates Recalled for Undeclared Wheat Risk

Neuhaus nv recalled 100 pieces of ORIGINAL BELGIAN CHOCOLATE on August 4, 2025, due to undeclared wheat. The recall affects products distributed in Virginia, Maryland, Pennsylvania, New York, and Washington D.C.

Neuhaus nv
Product contains
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HIGHFDA DEVICE

AVID Medical Recalls Convenience Kit Over Sterility Risk

AVID Medical recalled 57 units of the Halyard ENT Pack on August 4, 2025. The recall stems from potential open header bag seals that may compromise sterility. Patients and healthcare providers must stop using this device immediately.

AVID Medical
Potential for
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HIGHFDA FOOD

Hans Kissle Potato Salad Recalled for Undeclared Wheat Hazard

Hans Kissle Company recalled 66 units of Red Bliss Potato Salad on August 4, 2025, due to undeclared wheat. The product is mislabeled as potato salad but contains pasta salad. Consumers should not eat the product and should seek a refund or replacement.

Hans Kissle Company
Contains undeclared
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