These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

2,247 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
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 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

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 DEVICE

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

Shanghai United Imaging Healthcare Co., Ltd. recalled 11 units of its uCT 760 MD Computed Tomography X-ray System on September 12, 2025. The recall addresses a serious hazard where third-party outer covers can become trapped between the patient table and gantry, leading to mechanical interference. Healthcare providers and patients must stop using the device immediately and follow recall directives

UIH Technologies
Third-party outer
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HIGHFDA DEVICE

GE HealthCare Recalls Nuclear Medicine Camera Over Fall Risk

GE HealthCare recalled 28 dual-head gamma cameras on September 12, 2025. The recall comes after concerns that inadequate support during relocation could lead to a detector fall. This situation poses a high risk of life-threatening injury.

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 HealthCare Recalls Cardial Nuclear Medicine Cameras Over Fall Risk

GE HealthCare recalled 11 Cardial nuclear medicine gamma cameras on September 12, 2025. The recall follows concerns over inadequate detector support potentially leading to life-threatening falls. The affected systems were transported without proper safeguards, compromising safety.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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HIGHFDA DRUG

Major Pharmaceuticals Recalls Chlorpromazine Tablets Over Contaminant Hazard

Major Pharmaceuticals recalled 866 blister packs of Chlorpromazine Hydrochloride Tablets on September 12, 2025. The recall follows the detection of N-Nitroso Desmethyl Chlorpromazine above safe limits. The affected products were distributed nationwide and are classified as a Class II hazard.

Major Pharmaceuticals
CGMP Deviations:
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HIGHFDA DEVICE

UIH Technologies Recalls PET/CT System Due to Mechanical Hazard

UIH Technologies recalled 95 units of its uMI 550 Positron Emission Tomography and Computed Tomography System on September 12, 2025. Third-party outer covers can trap between the patient table and gantry, posing a mechanical interference risk. Patients and healthcare providers must stop using the device immediately.

UIH Technologies
Third-party outer
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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 DEVICE

GE HealthCare Recalls Nuclear Medicine Gamma Camera Over Fall Risk

GE HealthCare recalled 64 units of the Elscint Model 4XX gamma camera on September 12, 2025. The recall affects systems that lack adequate support during transport, risking detector falls. If the detectors fall, they can cause serious injuries to patients and healthcare providers.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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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 Gamma Cameras Due to Fall Hazard

GE HealthCare recalled 102 dual-head nuclear medicine gamma cameras on September 12, 2025. The recall stems from inadequate support during transportation that could lead to a detector fall, posing a life-threatening injury risk. The affected devices are past their End of Guaranteed Service and should not be used immediately.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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HIGHFDA DEVICE

UIH Technologies Recalls PET/CT System Over Mechanical Interference Risk

UIH Technologies recalled two units of the uEXPLORER MD system on September 12, 2025. Third-party covers can trap between the patient table and gantry, causing mechanical interference. Healthcare providers must stop using the device immediately and follow recall instructions.

UIH Technologies
Third-party outer
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