Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Hair Mineral Analysis Recall 19 Units (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
fda regulated Recalls
1,320 recalls tagged with “fda regulated”.
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Kidney Test Recalled for 100 Units in 2025
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB NAD Profile Test Recall 36 Units for Premarket Approval Issue (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Vitamin D2 and D3 Test Recall 10 Units Sold Nationwide (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Recalled GI Microbiome Profile XL
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Recalled 754 Units of 2 in 1 Trichomonas / Gardnerella Test (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Blood Type Test Recalled for Lack of Premarket Approval (47 Units) 2025
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Cholesterol Test Recall 2025 for 80 Units Nationwide
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Ferritin Iron Deficiency Test Recalled for Premarket Approval Issue (202
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB 8 in 1 STI Test Kit Recalled for 2,043 Units in 2025
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
Orthofix Recalls CONSTRUX Mini PTC Spacer System Due to Labeling Issues
Labeling contains claims that are not consistently present.
Orthofix U.S.
Labeling contains
Health & Personal Care
HIGH
FDA 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
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Recalls Sperm Test Due to Approval Issues
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
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Thyroid TSH Test Recalled Over PMA Issue (1,916 Units)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Allergy Test Small Recalled for Lack of Premarket Approval (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Parasite Test Recalled for Distribution Without Premarket Approval
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Peptic Ulcer Test Recalled 12 Units in 2025
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB DHEA Test Recalled for Premarket-Approval Lapse, 17 Units (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Recalls Vitamin D-Test Over Approval Issues
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA 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.
GET TESTED INTERNATIONAL AB
Distribution without
Tag Statistics
Total Recalls
1,320