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

2,251 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

GET TESTED INTERNATIONAL AB Recalls Iron Deficiency Test

GET TESTED INTERNATIONAL AB recalled 115 units of its Iron Deficiency Test on November 3, 2025. The recall stems from distribution without premarket approval. Patients and healthcare providers must stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Mycotoxin Panel Test

GET TESTED INTERNATIONAL AB recalled 2 units of its Mycotoxin Panel Test on November 3, 2025. The recall follows distribution without necessary premarket approval. Consumers must stop using the product immediately and follow the provided instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Food Intolerance Test Medium

GET TESTED INTERNATIONAL AB recalled 16 units of Food Intolerance Test Medium on November 3, 2025. The recall stems from distribution without premarket approval. Consumers should stop use immediately and follow provided instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Hair Mineral Analysis Device

GET TESTED INTERNATIONAL AB recalled 19 units of its Hair Mineral Analysis device on November 3, 2025. The recall follows distribution without premarket approval or clearance. This action affects devices distributed nationwide in the U.S.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls GI Microbiome Profile Small

GET TESTED INTERNATIONAL AB recalled one GI Microbiome Profile Small on November 3, 2025. The recall stems from distribution without premarket approval. This recall affects healthcare providers and patients across the United States.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Menopause Tests Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 184 units of Menopause (FSH) 2 Tests on November 3, 2025. This recall occurred due to distribution without premarket approval or clearance. Healthcare providers and patients must stop using the tests immediately and follow recall instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

Medtronic MiniMed 780G Insulin Pump Recalled Over Software Issue

Medtronic MiniMed recalled 577 units of the MiniMed 780G insulin pump on November 2, 2025. A software flaw in version 6.60 may cause insulin delivery to suspend unexpectedly, posing serious health risks. Patients should stop using the device immediately and follow recall instructions.

Medtronic MiniMed
A software
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HIGHFDA DEVICE

Stryker Recalls NICO Myriad Handpieces Over Latex Allergy Risk

Stryker recalled 39,148 NICO Myriad Handpieces on October 31, 2025, due to a latex hazard. The packaging tape contains latex despite products being labeled latex-free. This poses a significant allergy risk to patients and healthcare providers.

Stryker
Tape used
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HIGHFDA DEVICE

Stryker MV3 Bariatric Bed Recalled Over Compatibility Issues

Stryker Medical recalled 286 MV3 bariatric beds on October 31, 2025. The beds may not be compatible with Arise 1000EX mattresses, posing risks to patients. Healthcare providers and patients must stop using the beds immediately.

Stryker Medical Division of Stryker
Stryker has
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HIGHFDA FOOD

Indian Cookware Recalls Kadai Due to Lead Contamination Risk

Indian Cookware and Appliance LLC recalled 10 pieces of Aluminium Hammered Kadai on October 31, 2025. The products may contain leachable lead, posing a health risk. Consumers should stop using the product and seek a refund or replacement immediately.

INDIAN COOKWARE AND APPLIANCE
Potential contamination
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HIGHFDA DRUG

Nivagen Zinc Oxide Ointment Recalled Due to cGMP Deviations

Nivagen Pharmaceuticals recalled 13,536 containers of zinc oxide ointment on October 31, 2025. The recall follows deviations from current Good Manufacturing Practices (cGMP). Consumers must stop using the product immediately and contact healthcare providers for guidance.

NIVAGEN ZINC OXIDE
cGMP deviations
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HIGHFDA DEVICE

Philips IntelliVue MP5 Monitors Recalled Over Alarm Failure

Philips North America recalled 1,913,441 IntelliVue MP5 monitors on October 31, 2025, due to a failure to alarm. The recall affects devices distributed worldwide, including the United States. Patients and healthcare providers must stop using the monitors immediately.

Philips North America
Potential issue
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