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

Orthofix Recalls PTC Spacer Systems Over Labeling Issues

Orthofix U.S. LLC recalled 13,317 PTC Spacer Systems on November 3, 2025, due to inconsistent labeling claims. The recall affects multiple model numbers sold worldwide, including in the U.S. The company advises immediate cessation of use and communication with healthcare providers.

Orthofix U.S.
Labeling contains
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Candida Test for Lack of Approval

GET TESTED INTERNATIONAL AB recalled 109 units of its Candida Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers should stop using this device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Issues Recall for HPV Antigen Test

GET TESTED INTERNATIONAL AB recalled 258 HPV Antigen Tests on November 3, 2025. The tests were distributed nationwide without premarket approval or clearance. Healthcare providers and patients must stop using these devices immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Issues Recall of Alcohol Test Kit

GET TESTED INTERNATIONAL AB recalled one unit of its Alcohol Test Saliva on November 3, 2025, due to distribution without premarket approval. The recall affects the entire lot of this medical device. Consumers 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 Issues Recall for Pet Allergy Test

GET TESTED INTERNATIONAL AB recalled 29 Pet Allergy Test units on November 3, 2025. The recall follows 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 8 in 1 STI Test Kit

GET TESTED INTERNATIONAL AB recalled 2,043 units of its 8 in 1 STI Test Kit on November 3, 2025. The recall resulted 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 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 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 Organic Acids Test Due to Hazard

GET TESTED INTERNATIONAL AB recalled four units of its Organic Acids Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Healthcare providers and patients must stop using the device immediately and follow the manufacturer's instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Vitamin D2 and D3 Test

GET TESTED INTERNATIONAL AB recalled 10 units of its Vitamin D2 and D3 Test on November 3, 2025. The recall follows distribution without premarket approval. Patients and healthcare providers must stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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