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

1,498 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 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.

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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.

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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.

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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.

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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.

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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.

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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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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.

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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.

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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.

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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.

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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.

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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.

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