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

2,324 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 PSA Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 27 units of the PSA Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers must stop using the test immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Lactose Intolerance Test

GET TESTED INTERNATIONAL AB recalled 15 units of its Lactose Intolerance Test on November 3, 2025. The recall stems from 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

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

GVS TM Recalls Blood Transfusion Filter Over Sterility Concerns

GVS TM, Inc recalled 2,720 SQ40S Blood Transfusion Filters on November 3, 2025. The recall follows concerns that the sterility assurance cannot be confirmed due to incomplete quality control processes. Healthcare providers and patients must stop using the device immediately.

GVS TM
Due to
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Gut Microbiome Test XL

GET TESTED INTERNATIONAL AB recalled four units of the Gut Microbiome Test XL on November 3, 2025. The recall occurred due to distribution without premarket approval. Healthcare providers and patients should stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

Fresenius Kabi USA Recalls Ivenix Infusion System for Alarm Issues

Fresenius Kabi USA recalled 15,862 Ivenix Infusion Systems on November 3, 2025. The recall affects model LVP-0004 due to downstream occlusion alarms during low flow infusions. Healthcare providers and patients should stop using the device immediately.

Fresenius Kabi USA
Downstream Occlusion
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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 Parasite Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 94 units of its Parasite Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients should stop using the device immediately and follow provided instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalled GI Microbiome Profile XL

GET TESTED INTERNATIONAL AB recalled the GI Microbiome Profile XL on November 3, 2025, due to distribution without premarket approval. Three units were distributed nationwide in the U.S. 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 Recalls Vitamin D-Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 1,557 Vitamin D-Tests on November 3, 2025, due to distribution without premarket approval. The recall affects devices distributed nationwide in the United States. Consumers should stop using the test immediately and follow manufacturer 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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