689 recalls tagged with “fda regulated”.
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 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.
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.
GET TESTED INTERNATIONAL AB recalled 33 units of its sperm 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 recalled 80 cholesterol test devices on November 3, 2025. The recall occurred due to distribution without premarket approval. Patients should stop using the devices immediately and follow the manufacturer’s instructions.
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 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 recalled 47 blood type tests on November 3, 2025. The recall results from distribution without premarket approval. Patients and healthcare providers must stop using the device immediately and follow manufacturer instructions.
GET TESTED INTERNATIONAL AB recalled 754 units of its 2 in 1 Trichomonas / Gardnerella Test on November 3, 2025. The recall follows distribution without premarket approval. Patients and healthcare providers must stop using the product immediately.
GET TESTED INTERNATIONAL AB recalled 31 units of the Leaky Gut Test on November 3, 2025. The recall follows distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled 3 units of the Food Sensitivity 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 recalled 1,210 units of its 3 in 1 STI Test on November 3, 2025. The recall occurred due to distribution without the necessary premarket approval. Patients and healthcare providers must stop using the device immediately.
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 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 recalled 31 units of its Female Fertility Test on November 3, 2025. The product was distributed without required premarket approval or clearance. Users must stop using the device and follow the manufacturer's instructions.
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 recalled three Food Sensitivity Test devices on November 3, 2025. The recall follows the distribution of the devices without necessary premarket approval or clearance. Healthcare providers and patients must stop using the device immediately.
GET TESTED INTERNATIONAL AB recalled 60 units of its Trichomonas Vaginalis test on November 3, 2025. The recall follows distribution without proper premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.
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 recalled 5 units of its Food Intolerance Test Small on November 3, 2025. The recall follows the distribution of the device without necessary premarket approval. Healthcare providers and patients must cease use immediately and follow the manufacturer's instructions.