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
immediate action Recalls
2,756 recalls tagged with “immediate action”.
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
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 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
GET TESTED INTERNATIONAL AB Recalls Mycoplasma Test Over Approval Issues
GET TESTED INTERNATIONAL AB recalled 23 units of its Mycoplasma test on November 3, 2025. The recall occurred due to distribution without premarket approval, classified as Class II. 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 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 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 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 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 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 Recalls Allergy Test IgE Due to Approval Issues
GET TESTED INTERNATIONAL AB recalled 71 units of its Allergy Test IgE on November 3, 2025. The recall follows distribution without premarket approval, classified as Class II. Patients and healthcare providers should stop using the device immediately.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Recalls Lactose Intolerance Test
GET TESTED INTERNATIONAL AB recalled 15 units of its Lactose Intolerance 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 Recalls Urinary Tract Infection Test Due to Approval Issues
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
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 Recalls Gut Microbiome Test XL
GET TESTED INTERNATIONAL AB recalled four units of the Gut Microbiome Test XL on November 3, 2025. The recall occurred due to distribution without premarket approval. Healthcare providers and patients should stop using the device immediately.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
Fresenius Kabi USA Recalls Ivenix Infusion System for Alarm Issues
Fresenius Kabi USA recalled 15,862 Ivenix Infusion Systems on November 3, 2025. The recall affects model LVP-0004 due to downstream occlusion alarms during low flow infusions. Healthcare providers and patients should stop using the device immediately.
Fresenius Kabi USA
Downstream Occlusion
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 HSV Test Kit Recalled for 1,361 Units in 2025
Distribution without premarket approval/clearance.
Get Tested International AB
Distribution without
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