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

Siemens Medical Solutions Recalls Fluoroscopic X-Ray System

Siemens Medical Solutions USA recalled 20 Artis Pheno. Image-Intensified Fluoroscopic X-Ray Systems due to limited system movements after startup. The recall, announced on August 12, 2025, affects devices distributed nationwide across several states.

Siemens Medical Solutions USA
Limited system
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HIGHFDA FOOD

Wegmans Cheese Flight Recalled Due to Listeria Contamination

Wegmans Food Markets recalled 4,884 units of its Assorted Cheese Flight on August 12, 2025. The product may be contaminated with Listeria monocytogenes, a serious foodborne pathogen. The recall affects consumers in NY, PA, MA, NJ, MD, VA, NC, DE, CT, and DC.

Wegmans Food Markets
Products may
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HIGHFDA FOOD

Wegmans Camembert Cheese Recalled Due to Listeria Risk

Wegmans Food Markets recalled 4,884 units of Medium Camembert Soft Ripened Cheese on August 12, 2025. The product may be contaminated with Listeria monocytogenes, posing a serious health risk. Consumers should not eat the cheese and should contact the company for refunds.

Wegmans Food Markets
Products may
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HIGHFDA FOOD

H & N Group Recalls Frozen Shrimp Over Contamination Risk

H & N Group recalled 17,214 cases of frozen shrimp on August 12, 2025. The product may be contaminated with Cesium-137 due to unsanitary manufacturing conditions. Consumers should not consume the shrimp and seek refunds immediately.

H & N Group
Product manufactured
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HIGHFDA FOOD

Wegmans Brie Cheese Recalled Due to Listeria Risk

Wegmans Food Markets recalled 4,884 units of Caramel Apple Pecan Topped Brie Cheese on August 12, 2025. The cheese may be contaminated with Listeria monocytogenes, a serious pathogen. Consumers should not consume this product and seek a refund.

Wegmans Food Markets
Products may
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HIGHFDA FOOD

Baker's Authority Graham Cracker Meal Recalled Over Allergen Risks

Baker's Authority recalled 70 units of Graham Cracker Meal on August 12, 2025, due to undeclared allergens. The product lacks proper labeling for wheat and soy, posing a serious health risk to allergic consumers. These items were distributed across multiple states including NY, CA, and TX.

Bakers Authority
Product label
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HIGHFDA DEVICE

Max Mobility Recalls Smart Drive MX2+ Due to Control Hazard

Max Mobility recalled 8,413 Smart Drive MX2+ SpeedControl Dials on August 12, 2025. A faulty electrical connection poses a risk of losing control of the wheelchair, leading to potential injuries. Healthcare providers should stop using the device immediately and follow recall instructions.

Max Mobility
Due to
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HIGHFDA DEVICE

Agilent Technologies Recalls FLEX Monoclonal Antibody Over False Negatives

Agilent Technologies recalled 67 units of FLEX Monoclonal Mouse Anti-Human CD20cy on August 11, 2025. The recall stems from the potential for weak staining leading to false negative results in B-cell identification. Healthcare providers must cease use immediately and follow recall instructions.

Agilent Technologies Denmark ApS
Their is
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HIGHFDA DEVICE

Agilent Technologies Recalls FLEX Monoclonal Antibody Due to Staining Issues

Agilent Technologies Denmark ApS recalled 65 units of its FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26 on August 11, 2025. The recall stems from potential weak staining that could lead to false negative CD20 identification. Healthcare providers and patients should stop using the product immediately.

Agilent Technologies Denmark ApS
Their is
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HIGHFDA DRUG

Lannett Recalls Lisdexamfetamine Capsules Over Labeling Error

Lannett Company recalled 8,544 bottles of Lisdexamfetamine Dimesylate Capsules on August 11, 2025. The recall occurred due to a labeling mix-up where 40 mg capsules were mislabeled as 30 mg. This issue poses a high risk to consumers who may receive incorrect dosages.

Lisdexamfetamine Dimesylate
Labeling: Label
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HIGHFDA DEVICE

Agilent Technologies Recalls FLEX Monoclonal Antibody Due to False Negatives

Agilent Technologies Denmark ApS recalled 4,145 units of FLEX Monoclonal Mouse Anti-Human CD20cy on August 11, 2025. The recall stems from potential weak staining that may lead to false negative CD20 identification. Healthcare providers and patients must stop using the product immediately.

Agilent Technologies Denmark ApS
Their is
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HIGHFDA DRUG

Glenmark Pharmaceuticals Recalls Theophylline Tablets Over Dissolution Issues

Glenmark Pharmaceuticals Inc. recalled 22,656 bottles of Theophylline extended-release tablets on August 8, 2025. The recall follows reports of failed dissolution specifications that could impact medication efficacy. Consumers should stop using the product and consult healthcare providers immediately.

Glenmark Pharmaceuticals Inc.
Failed Dissolution
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HIGHFDA FOOD

SUNGAL Canned Half Plum Recalled Due to Cyclamate Contamination

SUNGAL recalled 29 cases of canned Half Plum on August 8, 2025, due to cyclamate adulteration. The affected product may pose a health risk. Consumers in California, Maryland, New York, and Virginia should stop using the product immediately.

SUNGAL
Cyclamate adulteration
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HIGHFDA DEVICE

Philips Medical Systems Recalls IntelliSpace Cardiovascular Software

Philips Medical Systems Nederland B.V. recalled its IntelliSpace Cardiovascular Software 8.0.0.4 on August 8, 2025. The recall affects four units distributed nationwide, particularly in Georgia, North Carolina, and Texas. The software displays outdated information, posing a significant risk to patient safety.

Philips Medical Systems Nederland B.V.
Software issue
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HIGHFDA DRUG

Quallent Pharmaceuticals Recalls Duloxetine Capsules Over Impurity Risk

Quallent Pharmaceuticals recalled 3,591 bottles of Duloxetine Delayed-Release Capsules on August 8, 2025. The recall stems from CGMP deviations regarding an impurity exceeding safety limits. Consumers should stop using the product immediately and contact their healthcare provider.

DULOXETINE
CGMP deviations:
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