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 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
Read more
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
Read more
HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Food Allergy Panel Test

GET TESTED INTERNATIONAL AB recalled three units of its Food Allergy Panel Test (IgE) on November 3, 2025. The recall follows distribution without premarket approval. The company advises immediate cessation of use and provides further instructions for patients and healthcare providers.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
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
Read more
HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Issues Chlamydia Test Recall

GET TESTED INTERNATIONAL AB recalled five Chlamydia Tests on November 3, 2025. The recall occurred due to distribution without premarket approval. Healthcare providers and patients must cease use immediately and follow the manufacturer's instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
HIGHFDA DEVICE

Fresenius Kabi Recalls Infusion System Due to Assembly Error

Fresenius Kabi USA recalled 12,075 infusion pump administration sets on November 3, 2025. The recall stems from incorrect assembly that poses a serious risk of patient injury. Healthcare providers and patients should stop using the devices immediately.

Fresenius Kabi USA
Incorrect assembly
Read more
HIGHFDA FOOD

Dreyer's Grand Ice Cream Recalls Haagen-Dazs Bars Over Undeclared Wheat

Dreyer's Grand Ice Cream recalled 3,410 cases of Haagen-Dazs mini chocolate dark chocolate ice cream bars on November 3, 2025. The recall occurred due to undeclared wheat, which poses a serious health risk to individuals with wheat allergies. The affected products were distributed in California, Kentucky, Ohio, and Wisconsin.

Dreyer's Grand Ice Cream
Undeclared wheat.
Read more
HIGHFDA DEVICE

Orthofix Recalls CONSTRUX Mini Ti Spacer System Over Labeling Issues

Orthofix U.S. recalled 40,956 units of the CONSTRUX Mini Ti Spacer System on November 3, 2025. Labeling inconsistencies pose potential risks to patients and healthcare providers. Users should stop using the device immediately and follow recall instructions.

Orthofix U.S.
Labeling contains
Read more
HIGHFDA DEVICE

Orthofix Recalls CONSTRUX Mini PTC Spacer System Due to Labeling Issues

Orthofix U.S. recalled 61,977 units of the CONSTRUX Mini PTC Spacer System on November 3, 2025. The recall impacts various model numbers due to inconsistent labeling claims. Consumers should stop using the product immediately and follow manufacturer instructions for a refund.

Orthofix U.S.
Labeling contains
Read more
HIGHFDA DEVICE

Orthofix Recalls Ti Spacer System Due to Labeling Issues

Orthofix U.S. LLC recalled 14,201 units of the Forza Ti Spacer System on November 3, 2025. The recall stems from inconsistent labeling claims that may mislead users. Patients and healthcare providers should stop using the product immediately and follow recall instructions.

Orthofix U.S.
Labeling contains
Read more
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
Read more
HIGHFDA DEVICE

Philips Ultrasound System Recalled Over Compatibility Issues

Philips Ultrasound recalled 4,819 diagnostic ultrasound systems on October 31, 2025. The recall affects models 795005, 795161, and 989605449841 due to compatibility issues with Apple devices running iOS 18. These issues may prevent the systems from performing live imaging, posing risks in medical settings.

Philips Ultrasound
Ultrasound system
Read more
Advertisement