fda regulated Recalls

842 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Trichomonas Vaginalis Test Recalled for Lack of Premarket Approval (2025

GET TESTED INTERNATIONAL AB recalled 60 Trichomonas Vaginalis tests distributed nationwide in the United States after regulators found no premarket approval or clearance. The recall stems from a violation of regulatory requirements. Patients and healthcare providers should stop using this device immediately and follow the manufacturer’s recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls 6 Gut Microbiome Test Small Kits for Premarket Approval Violat​e

GET TESTED INTERNATIONAL AB recalled 6 Gut Microbiome Test Small units distributed nationwide in the United States. The devices were distributed without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.

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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.

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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.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Mycotoxin Panel Test Recalled for 2 Units in 2025

GET TESTED INTERNATIONAL AB's Mycotoxin Panel Test was recalled after two units were distributed nationwide in the United States. The recall cites distribution without premarket approval or clearance. Consumers should stop using the device immediately and follow the manufacturer’s recall instructions or contact a healthcare provider for guidance.

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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

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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.

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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.

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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.

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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
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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.

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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.

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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.

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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.

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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.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL Gut Microbiome Test Large Recalled for Premarket-Approval Violation (2025)

GET TESTED INTERNATIONAL recalled 3 Gut Microbiome Test Large kits sold nationwide in the United States after regulators flagged distribution without premarket approval. The recall centers on a lack of FDA clearance for the device. Consumers and healthcare providers should stop using the device immediately and follow recall instructions.

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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

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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.

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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

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Tag Statistics

Total Recalls
842

Related Tags

mandatory standard violationreturn for refundstop use immediatelyimmediate actionreplacement availablenhtsa regulatedfederal law violationcpsc regulatedadult productinfant producttoddler productglass