All Product Recalls

Browse through 1,551 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.

HIGHFDA DRUG

Unique Pharmaceuticals Recalls Cetirizine Tablets Over Wrong ID Imprint

Unique Pharmaceuticals Labs recalled 9,936 bottles of Cetirizine Hydrochloride Tablets on September 12, 2025. The tablets were imprinted with the wrong ID, posing a potential health risk. Consumers should stop using the product immediately and seek guidance from healthcare providers.

CETIRIZINE HYDROCHLORIDE
Tablet/Capsules Imprinted
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HIGHFDA DEVICE

GE HealthCare Recalls Nuclear Medicine Camera Over Fall Risk

GE HealthCare recalled three units of the Elscint Helix nuclear medicine gamma camera on September 12, 2025. The recall affects systems that may have been transported without proper support, risking detector falls. This issue poses a high risk of life-threatening injuries.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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HIGHFDA DEVICE

GE HealthCare Recalls Nuclear Medicine Camera Over Fall Risk

GE HealthCare recalled 37 nuclear medicine gamma cameras on September 12, 2025. The recall follows concerns that inadequate detector support during transport could lead to life-threatening falls. The affected systems are past the End of Guaranteed Service and pose serious risks to patients and healthcare providers.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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HIGHFDA DEVICE

Shanghai United Imaging Healthcare Recalls X-ray System Due to Hazard

Shanghai United Imaging Healthcare Co., Ltd. recalled two units of its uCT 780 MD Computed Tomography X-ray System on September 12, 2025. Third-party outer covers can trap between the patient table and gantry, causing mechanical interference. This recall affects units distributed in the US and internationally.

UIH Technologies
Third-party outer
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HIGHFDA DRUG

Major Pharmaceuticals Recalls Chlorpromazine Tablets Over Contamination Risk

Major Pharmaceuticals recalled 2,064 blister packs of Chlorpromazine Hydrochloride Tablets on September 12, 2025. The recall follows the discovery of N-Nitroso Desmethyl Chlorpromazine exceeding safe limits. Consumers must stop using this product immediately and consult healthcare providers for guidance.

Major Pharmaceuticals
CGMP Deviations:
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HIGHFDA DEVICE

Philips Recalls Cardiac Workstation 5000 Over Electrical Hazard

Philips North America recalled 28 units of the Cardiac Workstation 5000 on September 12, 2025. A pinched power module wire within the device can cause a short, posing a high risk of electrical hazards. Healthcare providers and patients should stop using the device immediately.

Philips North America
Failure of
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HIGHFDA DRUG

Major Pharmaceuticals Recalls Chlorpromazine Tablets Over Contamination

Major Pharmaceuticals announced a recall of 1,256 blister packs of Chlorpromazine Hydrochloride Tablets on September 12, 2025. The recall stems from the presence of N-Nitroso Desmethyl Chlorpromazine above safe intake levels. Consumers must stop using the product immediately and contact their healthcare provider for guidance.

Chlorpromazine Hydrochloride
CGMP Deviations:
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HIGHFDA DEVICE

GE HealthCare Recalls Gamma Camera Due to Fall Hazard

GE HealthCare recalled 82 units of the Millenium Myosight gamma camera on September 12, 2025. The recall affects systems that may lack sufficient support during transport, posing a risk of detector falls. This defect can result in life-threatening injuries.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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HIGHFDA DEVICE

Shanghai United Imaging X-ray System Recalled Due to Mechanical Hazard

Shanghai United Imaging Healthcare Co., Ltd. recalled 22 units of its uCT 550 MD X-ray system on September 12, 2025. The recall was issued after reports that third-party outer covers can trap between the patient table and gantry. This can cause mechanical interference during table movement, posing a high risk to patients and healthcare providers.

UIH Technologies
Third-party outer
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HIGHFDA DEVICE

UIH Technologies Recalls PET/CT System Over Mechanical Hazard

Shanghai United Imaging Healthcare Co., Ltd. recalled four units of its Positron Emission Tomography and Computed Tomography System on September 12, 2025. The recall stems from a risk of mechanical interference during table movement due to third-party outer covers. Healthcare providers and patients must stop using the device immediately.

UIH Technologies
Third-party outer
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HIGHFDA DEVICE

GE Medical Systems Recalls Nuclear Medicine Gamma Cameras Over Hazard

GE HealthCare recalled 205 dual-head nuclear medicine gamma cameras on September 12, 2025. The recall affects models that may have been relocated without proper detector support, leading to potential falls. This issue poses a high risk of life-threatening injury.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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HIGHFDA DEVICE

GE Healthcare Recalls Nuclear Medicine Cameras Due to Fall Risk

GE HealthCare recalled 15 nuclear medicine gamma cameras on September 12, 2025. The recall affects systems that may have been relocated without proper support, risking detector falls. This poses a significant danger of life-threatening injuries to patients and healthcare providers.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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HIGHFDA DEVICE

GE HealthCare Issues Recall of Nuclear Medicine Camera Due to Fall Risk

GE HealthCare recalled a dual-head nuclear medicine gamma camera on September 12, 2025, after identifying a risk of detector falls. One unit is affected, posing a high risk of life-threatening injury. Users must stop using the device immediately and follow manufacturer instructions.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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HIGHFDA DEVICE

GE HealthCare Recalls Nuclear Medicine Gamma Cameras Over Fall Risk

GE HealthCare recalled 1,386 nuclear medicine gamma cameras on September 12, 2025. Certain models may have been relocated without proper support, risking detector integrity. This could lead to life-threatening injuries from falls.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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HIGHFDA DEVICE

GE HealthCare Recalls Nuclear Medicine Gamma Camera Due to Fall Risk

GE HealthCare recalled 45 dual-head nuclear medicine gamma cameras on September 12, 2025. The recall affects devices that may have been relocated without proper support, risking a detector fall. This defect can lead to life-threatening injuries.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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