stop use immediately Recalls

2,153 recalls tagged with “stop use immediately”.

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.

GET TESTED INTERNATIONAL AB
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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
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Pollen Allergy Test Due to Approval Issues

GET TESTED INTERNATIONAL AB recalled 10 units of the Pollen Allergy Test on November 3, 2025. The recall stems from distribution without necessary premarket approval. Patients should stop using the device immediately and follow manufacturer 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.

GET TESTED INTERNATIONAL AB
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Issues Recall for Pet Allergy Test

GET TESTED INTERNATIONAL AB recalled 29 Pet Allergy Test units on November 3, 2025. The recall follows distribution without premarket approval. Patients and healthcare providers must stop using the device immediately.

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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

Orthofix Recalls FORZA PTC Spacer System Over Labeling Issues

Orthofix U.S. recalled 34,582 units of its FORZA PTC Spacer System on November 3, 2025, due to inconsistent labeling claims. The recall affects multiple models sold worldwide, including the U.S. and several countries. Consumers and healthcare providers should stop using the product immediately.

Orthofix U.S.
Labeling contains
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Chlamydia Test Recall 2026 — 5 US Units Distributed, PMA Issue

GET TESTED INTERNATIONAL AB recalled 5 chlamydia test devices distributed nationwide in the United States after regulators found distribution without FDA premarket approval or clearance. The devices lack required premarket authorization. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's recall instructions.

GET TESTED INTERNATIONAL AB
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Lyme Test Recalled for 940 Units in 2025

GET TESTED INTERNATIONAL AB's Lyme Test devices were distributed nationwide in the United States to healthcare providers. Regulators found the devices were distributed without FDA premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

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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 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.

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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
LOW
FDA DEVICE

GET TESTED INTERNATIONAL AB Female Fertility Test Recalled for Premarket Approval Violation (31Units

GET TESTED INTERNATIONAL AB recalled 31 Female Fertility Tests distributed nationwide in the US. The devices were distributed without premarket approval or clearance. Patients and healthcare providers should 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 Issues Recall of Alcohol Test Kit

GET TESTED INTERNATIONAL AB recalled one unit of its Alcohol Test Saliva on November 3, 2025, due to distribution without premarket approval. The recall affects the entire lot of this medical device. Consumers 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.

GET TESTED INTERNATIONAL AB
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Health & Personal Care
HIGH
FDA DEVICE

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.

GET TESTED INTERNATIONAL AB
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