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

1,488 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

Diasol Recalls Dialysis Concentrate Over Safety Concerns

Diasol recalled 2,200 gallons of its 100425-10-DEX100 liquid concentrate for bicarbonate dialysis on November 5, 2025. The company cannot assure the safety and efficacy of the product. Patients and healthcare providers should stop using it immediately.

Diasol
Safety and
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HIGHFDA DEVICE

Diasol Recalls Dialysis Concentrate Over Safety Concerns

Diasol recalled 7,200 gallons of its 100125-10-DEX100 liquid concentrate on November 5, 2025. The recall affects dialysis patients in multiple states due to unassured safety and efficacy. Patients and healthcare providers must stop using this product immediately.

Diasol
Safety and
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HIGHFDA DEVICE

Diasol Recalls Dialysis Concentrate Over Safety Concerns

Diasol recalled 4,400 gallons of its 100230-10-DEX100 dialysis acid concentrate on November 5, 2025. The company cannot assure the safety and efficacy of this product. Healthcare providers and patients must stop using the concentrate immediately.

Diasol
Safety and
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HIGHNHTSA

Ford Explorer Recalled for Powertrain Software Issues

Ford recalled certain 2025 Explorer vehicles due to powertrain control module issues. The module may reset while driving, risking vehicle rollaway or engine stall. Notification letters were mailed to owners on June 6, 2025.

Ford Motor Company
A damaged
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HIGHNHTSA

Hyundai IONIQ 5 Recalled Over Brake Control Software Issue

Hyundai recalled certain 2025 IONIQ 5 vehicles on November 4, 2025, due to braking software issues. The integrated electronic brake and vehicle control unit may cause reduced braking performance and unintended acceleration. Owners must refrain from using left-foot braking or N e-shift features until repairs are completed.

Hyundai Motor America
Reduced braking
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HIGHFDA FOOD

Africa Imports Recalls Moringa Powder Due to Salmonella Risk

Africa Imports recalled Organic Moringa Leaf Powder on November 4, 2025, after it tested positive for Salmonella. The recall affects 31 units of M-P697KG sold in several states, including Texas and New York. Consumers should not consume the product and seek a refund immediately.

Africa Imports
Product tested
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HIGHFDA DEVICE

Datascope Recalls Intra-Aortic Balloon Pump Over Maintenance Issues

Datascope recalled 47 units of its Cardiosave Rescue Intra-Aortic Balloon Pump on November 4, 2025. The recall addresses a revised Preventative Maintenance schedule in the device's instructions for use. This issue poses a high risk to patient safety and requires immediate attention from healthcare providers.

Datascope
The IFU
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Food Intolerance Test Due to Approval Issues

GET TESTED INTERNATIONAL AB recalled 5 units of its Food Intolerance Test Small on November 3, 2025. The recall follows the distribution of the device without necessary premarket approval. Healthcare providers and patients must cease use immediately and follow the manufacturer's instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Organic Acids Test

GET TESTED INTERNATIONAL AB recalled one unit of its Organic Acids Profile Test Large on November 3, 2025. The recall occurred due to distribution without necessary premarket approval. Patients and healthcare providers should stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Medical Device Recalled for Illegal Marketing

GET TESTED INTERNATIONAL AB recalled one medical device on November 3, 2025, due to distribution without premarket approval. The recall affects the entire lot and requires immediate cessation of use. Patients and healthcare providers must follow the manufacturer’s instructions for safe disposal or return of the product.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Drug Test Over Approval Issue

GET TESTED INTERNATIONAL AB recalled one unit of its Drug Test Small on November 3, 2025. The recall occurred due to distribution without premarket approval or clearance. The FDA classified this recall as Class II, indicating a high risk to patients and healthcare providers.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Intestinal Worms Test

GET TESTED INTERNATIONAL AB recalled 45 units of its Intestinal Worms Test on November 3, 2025. The recall stems from distribution without necessary premarket approval or clearance. Healthcare providers and patients must stop using the product immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Heavy Metals Test for Approval Issues

GET TESTED INTERNATIONAL AB recalled 50 units of its Heavy Metals Test on November 3, 2025. The recall follows distribution without premarket approval or clearance, posing potential health risks. Healthcare providers and patients must stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Adrenal Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 17 units of its Adrenal Test on November 3, 2025. The recall occurred due to distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

Orthofix Recalls FIREBIRD SI Fusion System Over Labeling Issues

Orthofix U.S. recalled 19,431 units of its FIREBIRD SI Fusion System on November 3, 2025. The recall stems from inconsistent labeling claims that may mislead users. Affected models include multiple sizes of FIREBIRD SI Screws, sold worldwide.

Orthofix U.S.
Labeling contains
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