fda regulated Recalls

1,106 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB GI Microbiome Profile Small Recalled for Lack of Premarket Approval (202

GET TESTED INTERNATIONAL AB recalled 1 unit of GI Microbiome Profile Small sold nationwide in the United States. The device was distributed without premarket approval or clearance. Consumers should stop using the device immediately and follow the manufacturer’s recall instructions. Contact GET TESTED INTERNATIONAL AB or a healthcare provider for guidance.

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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.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Heavy Metals Test Recall for 50 Units (2025)

GET TESTED INTERNATIONAL AB recalled 50 units of Heavy Metals Test distributed nationwide in the United States. The device was distributed without premarket FDA approval or clearance. Stop using the device immediately and contact GET TESTED INTERNATIONAL AB for instructions.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalled 6 Food Intolerance Test Large Units for Premarket Issue (2025)

GET TESTED INTERNATIONAL AB recalled 6 Food Intolerance Test Large units sold nationwide in the US after a premarket approval issue. The device was distributed without premarket approval or clearance. Consumers should stop using the device immediately and contact GET TESTED INTERNATIONAL AB or their healthcare provider for instructions.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Peptic Ulcer Test Recalled 12 Units in 2025

GET TESTED INTERNATIONAL AB recalled 12 Peptic Ulcer Tests for H. pylori sold nationwide through multiple retailers. The tests were distributed without FDA premarket approval or clearance. Health professionals and patients should stop using the tests immediately and await recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB HbA1c Diabetes Test Recall Expands Nationwide (2025)

100% of reported issues involve distribution without premarket approval. GET TESTED INTERNATIONAL AB’s HbA1c Diabetes Test was distributed nationwide in the United States without FDA clearance. Stop using the product immediately and follow the manufacturer’s recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls 3 Food Sensitivity Test Small Units in 2025

GET TESTED INTERNATIONAL AB recalled 3 Food Sensitivity Test Small units distributed nationwide in the United States after a lack of premarket approval was identified. The recall is classified as Class II with a high-level hazard. Consumers should stop using the product immediately and follow the recall instructions from the manufacturer.

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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.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Food Sensitivity Test Large Recalled for 3 Units in 2025

GET TESTED INTERNATIONAL AB recalled 3 units of its Food Sensitivity Test Large sold nationwide in the United States. The device was distributed without FDA premarket approval or clearance. Consumers should stop using it and contact GET TESTED INTERNATIONAL AB or their healthcare provider for instructions.

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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 Allergy Test Small Recalled for Lack of Premarket Approval (2025)

GET TESTED INTERNATIONAL AB recalled 19 Allergy Test Small devices distributed nationwide in the United States after distribution without premarket approval or clearance. The devices were distributed without FDA clearance. Patients and healthcare providers should stop using this device immediately and contact GET TESTED INTERNATIONAL AB for 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 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 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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Tag Statistics

Total Recalls
1,106

Related Tags

immediate actionstop use immediatelyreturn for refundreplacement availablechemical hazardpoisoning riskelectronicbattery poweredcpsc regulatedholiday productadult productnhtsa regulated