electronic Recalls

325 recalls tagged with “electronic”.

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
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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.

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

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

GET TESTED INTERNATIONAL AB recalled 31 Leaky Gut Test devices distributed nationwide in the United States after the product was found to be distributed without FDA premarket approval. The devices test for gut health but lack FDA clearance. Consumers should stop using the device immediately and contact the manufacturer for instructions.

Get Tested International AB
Distribution without
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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

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

GET TESTED INTERNATIONAL AB Ferritin Iron Deficiency Test Recalled for Premarket Approval Issue (202

GET TESTED INTERNATIONAL AB recalled 115 ferritin iron deficiency tests distributed nationwide in the United States. The tests were distributed without FDA premarket approval or clearance. Stop using the device immediately and contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions.

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

GET TESTED INTERNATIONAL AB 8 in 1 STI Test Kit Recalled for 2,043 Units in 2025

GET TESTED INTERNATIONAL AB recalled 2,043 units of an 8 in 1 STI Test Kit sold nationwide in the United States. The recall is for distribution without premarket FDA approval or clearance. Consumers should stop using the device and follow the manufacturer’s recall instructions or contact the company for guidance.

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

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

GET TESTED INTERNATIONAL AB recalled 19 Hair Mineral Analysis devices 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 contact GET TESTED INTERNATIONAL AB or their healthcare provider for instructions.

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

GET TESTED INTERNATIONAL AB Recalls Parasite Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 94 units of its Parasite Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients should stop using the device immediately and follow provided instructions.

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

GET TESTED INTERNATIONAL AB IgE Food Allergy Panel Test Recalled in 2025

GET TESTED INTERNATIONAL AB recalled 3 units of its Food Allergy Panel Test (IgE) distributed nationwide in the United States after distribution without premarket approval was identified. The recall pertains to a regulatory lapse rather than an announced safety defect. Consumers should stop using the device immediately and follow manufacturer instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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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.

GET TESTED INTERNATIONAL AB
Distribution without
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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.

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

GET TESTED INTERNATIONAL AB Candida Test Recalled for 166 Units in 2025

GET TESTED INTERNATIONAL AB recalled 166 units of its Candida Test 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 recall instructions from the manufacturer.

GET TESTED INTERNATIONAL AB
Distribution without
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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.

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

Philips IntelliVue MX700 Recall Affects 1,913,441 Monitors Worldwide (2025)

Philips North America LLC is recalling 1,913,441 IntelliVue MX700 patient monitors (Product Number 865241) distributed worldwide. The monitors may fail to alarm. Hospitals and clinicians should stop using the affected devices immediately and follow the recall instructions.

Philips North America
Potential issue
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Health & Personal Care
HIGH
FDA DEVICE

Philips IntelliVue MX600 Patient Monitor Recall 2025 for Alarm Failure

Philips recalled 1,913,441 IntelliVue MX600 patient monitors distributed worldwide after reports that the devices did not alarm. The defect could prevent alarms that alert clinicians to patient distress. Hospitals and clinicians should stop using the devices immediately and follow the recall instructions from Philips North America LLC.

Philips
Potential issue
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