stop use immediately Recalls

2,229 recalls tagged with “stop use immediately”.

Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Akkermansia Test Recalled for 24 Units (2025)

GET TESTED INTERNATIONAL AB’s Akkermansia Test recall covers 24 units distributed nationwide in the United States. The device was distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Fructose Intolerance Test Recalled for 8 Units (2025)

GET TESTED INTERNATIONAL AB recalled 8 Fructose Intolerance Test devices distributed nationwide in the United States. The recall cites distribution without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's recall instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB PSA Test Recall 27 Units Distributed Nationwide 2025

GET TESTED INTERNATIONAL AB recalled 27 PSA Test devices distributed nationwide in the United States on 2025-11-03 after regulators found the device was distributed without premarket approval or clearance. The lack of PMA/clearance means the device did not receive required regulatory authorization before sale. Patients and healthcare providers should stop using the device immediately and follow 제조

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB DHEA Test Recalled for Premarket-Approval Lapse, 17 Units (2025)

GET TESTED INTERNATIONAL AB recalled 17 DHEA Test devices distributed nationwide in the United States after regulators flagged distribution without premarket approval. The devices lack FDA Premarket Approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB D-Dimer Test Recall for 1,218 Units (2025)

GET TESTED INTERNATIONAL AB recalled 1,218 D-Dimer Test kits nationwide after distributing without premarket approval. The recall cites distribution without FDA premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow all recall instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Sperm Test Recall for Premarket Violation (2025)

GET TESTED INTERNATIONAL AB recalled a single Sperm Test device distributed nationwide in the United States on 2025-11-03 due to distribution without FDA premarket approval or clearance. The device was not cleared for sale in the U.S. The company classified the recall as active. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall guidance

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls 16 Food Intolerance Test Medium Devices (2025)

GET TESTED INTERNATIONAL AB recalled 16 Food Intolerance Test Medium devices distributed nationwide in the United States. The devices were distributed without premarket approval or clearance. Consumers should stop using the device immediately and follow the manufacturer’s recall instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

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

GET TESTED INTERNATIONAL AB recalled 2 Gut Microbiome Test Mega units distributed nationwide in the United States. The recall centers on distribution without premarket approval or clearance. Consumers should stop using the device and contact the manufacturer for instructions. The notice was issued in 2025 and is currently active.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Biological Age & Longevity Test Recalled for Premarket Issue (3 Units,  

GET TESTED INTERNATIONAL AB recalled 3 units of the Biological Age & Longevity Test distributed nationwide in the United States. The recall concerns distribution without premarket approval or clearance. Consumers should stop using the device and follow the manufacturer's instructions. Contact GET TESTED INTERNATIONAL AB for guidance.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

Get Tested International AB HSV Test Kit Recalled for 1,361 Units in 2025

Get Tested International AB recalled 1,361 HSV-1 and HSV-2 Test Kits distributed nationwide in the United States after regulators found distribution without premarket approval. The test kit lacks FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's recall instructions by contacting Get Tested International AB.

Get Tested International AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Iodine Test Recall 2025 for 13 Units

GET TESTED INTERNATIONAL AB recalled 13 iodine test devices distributed nationwide in the United States. The devices were distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

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

GET TESTED INTERNATIONAL AB's gonorrhea test was distributed nationwide in the United States. The recall cites distribution without FDA premarket approval or clearance. Patients and healthcare providers should stop using the test immediately and follow the manufacturer's recall instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB MPOX Test Recall for 4 Units Distributed in US (2025)

GET TESTED INTERNATIONAL AB recalled 4 MPOX Test devices distributed nationwide in the United States after distribution without premarket approval. The recall cites a regulatory violation rather than an injury risk. Healthcare providers and patients should stop using the device immediately and await instructions from the manufacturer.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Serotonin Test Recall 12 Units (2025)

GET TESTED INTERNATIONAL AB recalled 12 serotonin test devices distributed nationwide in the United States after the device was distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall instructions. Contact GET TESTED INTERNATIONAL AB for instructions or consult your healthcare provider.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Kidney Test Recalled for 100 Units in 2025

GET TESTED INTERNATIONAL AB recalled 100 Kidney Test devices sold nationwide in the United States. The recall cites distribution without premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow manufacturer instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB NAD Profile Test Recall 36 Units for Premarket Approval Issue (2025)

GET TESTED INTERNATIONAL AB recalled 36 NAD Profile Tests distributed nationwide in the United States after regulators found distribution without premarket approval. The devices were distributed without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow recall instructions; contact GET TESTED INTERNATIONAL AB or your health‑ca

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

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

GET TESTED INTERNATIONAL AB recalled 10 Vitamin D2 and D3 Test kits distributed nationwide in the United States. The recall cites distribution without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalled 754 Units of 2 in 1 Trichomonas / Gardnerella Test (2025)

GET TESTED INTERNATIONAL AB recalled 754 units of a 2 in 1 Trichomonas / Gardnerella Test distributed nationwide in the United States after regulators found distribution without premarket approval or clearance. The device was distributed without FDA clearance. Patients and healthcare providers should stop using the test immediately and follow the manufacturer’s recall instructions by contactingGET

GET TESTED INTERNATIONAL AB
Distribution without
Read more