chemical hazard Recalls

Tops Strawberry Jam Recalled Over Unapproved Color Additive

GET TESTED INTERNATIONAL AB Hair Mineral Analysis Recall 19 Units (2025)

Distribution without premarket approval/clearance.

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 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 8 in 1 STI Test Kit Recalled for 2,043 Units in 2025

Distribution without premarket approval/clearance.

Get Tested International AB Leaky Gut Test Recalled for Lack of FDA Approval (31 Units)

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Vitamin D2 and D3 Test Recall 10 Units Sold Nationwide (2025)

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Gonorrhea Test Recalled for 463 Units in 2025

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Recalled Gut Microbiome Test Mega (2 Units) Over Premarket Approval Viol

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Parasite Test Recalled for Distribution Without Premarket Approval

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Recalls Food Intolerance Test Due to Approval Issues

Distribution without premarket approval/clearance.

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.

Fresenius Kabi USA Recalls 483 LVP Infusion Sets for IVENIX System Over Incorrect Assembly (2025)

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

GET TESTED INTERNATIONAL AB Issues Recall for HPV Antigen Test

GET TESTED INTERNATIONAL AB recalled 258 HPV Antigen Tests on November 3, 2025. The tests were distributed nationwide without premarket approval or clearance. Healthcare providers and patients must stop using these devices immediately.

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.

GET TESTED INTERNATIONAL AB Recalls Urinary Tract Infection Test Due to Approval Issues

Distribution without premarket approval/clearance.

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 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.

Blossom Pharmaceuticals Recalls Lanashield Skin Barrier Over cGMP Violations

Trifecta Pharmaceuticals Recalls Clotrimazole Cream for cGMP Violations