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
cpsc regulated Recalls
2,143 recalls tagged with “cpsc regulated”.
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
Orthofix Recalls Ti 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
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
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Recalled Gut Microbiome Test Mega (2 Units) Over Premarket Approval Viol
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
GVS TM Recalls Blood Transfusion Filter Over Sterility Concerns
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
GVS TM
Due to
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
Orthofix Recalls FORZA PTC Spacer System Over 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 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
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB MPOX Test Recall for 4 Units Distributed in US (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Serotonin Test Recall 12 Units (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 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 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 Leaky Gut Test Recalled for Lack of FDA Approval (31 Units)
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
Food & Beverages
HIGH
FDA FOOD
Haagen-Dazs Mini Chocolate Bars Recalled for Undeclared Wheat in 2025 (3,410 Cases)
Haagen-Dazs
Undeclared wheat.
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