Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Recalls 16 Food Intolerance Test Medium Devices (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
replacement available Recalls
1,216 recalls tagged with “replacement available”.
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 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 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 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 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 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 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 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
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
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 Hair Mineral Analysis Recall 19 Units (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Vehicles & Parts
HIGH
Health & Personal Care
HIGH
FDA DRUG
Nivagen Zinc Oxide Ointment Recall 912 Containers Over cGMP Deviations (2025)
Nivagen Zinc Oxide
cGMP deviations
Health & Personal Care
HIGH
FDA DEVICE
Philips IntelliVue MP5 M8105A Recall: 1,913,441 Monitors Worldwide Alarm Failure (2025)
Potential issue where the IntelliVue monitors did not alarm.
Philips
Potential issue
Health & Personal Care
HIGH
FDA DEVICE
Philips IntelliVue MX700 Recall Affects 1,913,441 Monitors Worldwide (2025)
Potential issue where the IntelliVue monitors did not alarm.
Philips North America
Potential issue