Health & Personal Care
LOW
FDA DEVICE
GET TESTED INTERNATIONAL AB Intestinal Worms Test Recalled for 45 Units Nationwide in 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 Recalled 6 Food Intolerance Test Large Units for Premarket Issue (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Drug Test Small (4 Substances) Recall 2025
GET TESTED INTERNATIONAL AB distributed 1 unit nationwide in the United States. The device lacked premarket approval or clearance. Stop using the product immediately and contact GET TESTED INTERNATIONAL AB for instructions.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA 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.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Recalls 6 Gut Microbiome Test Small Kits for Premarket Approval Violate
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB SIBO Test Recall: 55 Units in US Over Premarket Approval (2025)
GET TESTED INTERNATIONAL AB's SIBO Test was distributed nationwide in the United States. The device was distributed without FDA premarket approval or clearance. Stop using the device immediately and follow the recall instructions from the manufacturer.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Food Sensitivity Test Large Recalled for 3 Units in 2025
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Trichomonas Vaginalis Test 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 Akkermansia Test Recalled for 24 Units (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Fructose Intolerance Test Recalled for 8 Units (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 Mycotoxin Panel Test Recalled for 2 Units in 2025
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB PSA Test Recall 27 Units Distributed Nationwide 2025
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Syphilis Test Recalled in 2025 for PMA Lapse Nationwide
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB D-Dimer Test Recall for 1,218 Units (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Biological Age & Longevity Test Recalled for Premarket Issue (3 Units,
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Recalled 4 Organic Acids Test Kits for Distribution Without Premarket |
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
Get Tested International AB HSV Test Kit Recalled for 1,361 Units in 2025
Distribution without premarket approval/clearance.
Get Tested International AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Iodine Test Recall 2025 for 13 Units
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Gonorrhea Test Recalled for 463 Units in 2025
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without