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

Philips Recalls CT Systems Over Hazardous Couch Descent

Philips recalled 33 CT systems on August 13, 2025, due to a risk of the patient support table descending unexpectedly. A misalignment in the ball screw can cause the couch to drop to its lowest position. The recall affects models distributed worldwide, including the U.S. and numerous countries.

Philips North America
The patient
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HIGHFDA FOOD

Fresh & Ready Foods Recalls Sandwiches Over Undeclared Allergens

Fresh & Ready Foods LLC recalled 233 units of Piccolo Pranzo Box sandwiches on August 13, 2025. The recall follows the discovery of undeclared allergens, specifically wheat and milk, posing a serious risk to consumers. The recalled products were distributed to 15 locations across California.

Fresh & Ready Foods
undeclared allergen
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HIGHFDA DEVICE

Philips Recalls CT Systems Due to Fall Hazard

Philips recalled 81 IQon Spectral CT systems on August 13, 2025, due to a potential fall hazard. The patient support table may descend unexpectedly due to a ball screw misalignment. Healthcare providers and patients must stop using the device immediately.

Philips North America
The patient
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HIGHFDA DRUG

Sandoz Recalls Ciprofloxacin and Dexamethasone Otic Suspension Due to Temperature Abuse

Sandoz, Inc. recalled 1,680 bottles of Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension on August 13, 2025. The recall stems from temperature abuse that may compromise the product's efficacy. Consumers should stop using the product immediately and contact their healthcare provider or Sandoz for guidance.

CIPROFLOXACIN AND DEXAMETHASONE
Temperature Abuse
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HIGHFDA FOOD

Fresh & Ready Foods Recalls Sandwiches Over Wheat Allergen Risk

Fresh & Ready Foods recalled 233 units of ready to eat sandwiches on August 13, 2025. The recall stems from undeclared wheat allergens that pose a serious risk to consumers. The sandwiches were distributed to 15 corporate locations in California.

Fresh & Ready Foods
undeclared allergen
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HIGHFDA DEVICE

Philips Recalls CT Systems Over Risk of Unexpected Descent

Philips recalled three Ingenuity CT Family systems on August 13, 2025, due to a hazard that could lead to sudden descent. The issue stems from a ball screw misalignment affecting the patient support table. Users should stop using the devices immediately and follow recall instructions.

Philips North America
The patient
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HIGHFDA DEVICE

Philips CT Systems Recalled Due to Hazardous Couch Descent

Philips recalled 73 CT systems on August 13, 2025, due to a risk of the patient support table descending unexpectedly. The recall affects models 728240, 728246, and 728256 distributed worldwide. This recall includes systems sold across the US and several countries globally.

Philips North America
The patient
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HIGHFDA DEVICE

Philips CT Systems Recalled Due to Patient Support Table Hazard

Philips recalled 181 CT scanner units on August 13, 2025, due to a risk of the patient support table descending unexpectedly. The recall affects models 728235, 728231, and 728317 distributed worldwide. Healthcare providers and patients must stop using these devices immediately to ensure safety.

Philips North America
The patient
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HIGHFDA DEVICE

Philips Recalls CT Systems Over Risk of Unexpected Descent

Philips recalled 285 CT systems on August 13, 2025, due to a risk of patient support tables descending unexpectedly. The recall affects model numbers 728321, 728323, and 728326. Users should stop using the devices immediately and follow manufacturer instructions.

Philips North America
The patient
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HIGHFDA DEVICE

Philips CT System Recalled Due to Patient Safety Hazard

Philips recalled 210 Brilliance iCT CT systems on August 13, 2025. A misalignment in the ball screw may cause the patient support table to descend unexpectedly. Patients and healthcare providers must stop using the device immediately.

Philips North America
The patient
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HIGHFDA DEVICE

Philips Recalls CT Systems Over Risk of Unexpected Descent

Philips recalled 24 CT systems on August 13, 2025, due to a risk of the patient support table descending unexpectedly. The issue stems from a misalignment in a component after replacement. Health providers must stop using these devices immediately.

Philips North America
The patient
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HIGHFDA DEVICE

Beckman Coulter Recalls Hematology Analyzers Over High HGB Results

Beckman Coulter recalled the UniCel DxH 690T COULTER Cellular Analysis System on August 13, 2025. Erroneously high hemoglobin results may occur in patients with elevated white blood cell counts. Healthcare providers and patients must stop using the device immediately.

Beckman Coulter
Hematology analyzers
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HIGHFDA FOOD

Fresh & Ready Foods Recalls Ciabatta Sandwiches Over Allergen Risk

Fresh & Ready Foods LLC recalled 233 units of Spanish Club Ciabatta sandwiches on August 13, 2025. The recall stems from undeclared allergens, specifically wheat and milk, posing a high risk to consumers. The products were available at 15 corporate locations across California.

Fresh & Ready Foods
undeclared allergen
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HIGHFDA DEVICE

Beckman Coulter Recalls Hematology Analyzers Due to High HGB Risk

Beckman Coulter recalled its UniCel DxH 800 COULTER Cellular Analysis System on August 13, 2025. This recall affects devices that may produce inaccurately high hemoglobin results in patients with high white blood cell counts. The recall impacts worldwide distribution including numerous states in the U.S. and many countries.

Beckman Coulter
Hematology analyzers
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HIGHFDA DEVICE

Philips CT System Recalled Due to Hazardous Component Misalignment

Philips recalled 14 Brilliance iCT SP CT systems on August 13, 2025. The patient support table may descend unexpectedly due to a component misalignment. The recall affects devices distributed worldwide, including the US and 49 other countries.

Philips North America
The patient
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HIGHFDA DEVICE

Beckman Coulter Hematology Analyzer Recalled for High HGB Risk

Beckman Coulter recalled the UniCel DxH 900 COULTER Cellular Analysis System on August 13, 2025, due to erroneous high hemoglobin results. The devices may misreport hemoglobin levels on samples with elevated white blood cell counts. This recall affects devices distributed worldwide, including the U.S.

Beckman Coulter
Hematology analyzers
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HIGHFDA DEVICE

Max Mobility Recalls Smart Drive MX2+ Due to Control Hazard

Max Mobility recalled 15,834 Smart Drive MX2+ SpeedControl Dials on August 12, 2025. A faulty electrical connection may lead to loss of control, causing injuries. Users should stop using the device immediately and follow recall instructions.

Max Mobility
Due to
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HIGHFDA FOOD

Wegmans Grilling Camembert Recalled Due to Listeria Risk

Wegmans Food Markets recalled 4,884 units of Grilling Camembert on August 12, 2025, due to possible contamination with Listeria monocytogenes. The affected products are packaged in black and gold metal trays and distributed in several states including New York and Pennsylvania. Consumers should not consume this product and seek a refund or replacement.

Wegmans Food Markets
Products may
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