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

3,615 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
Food & Beverages
HIGH
FDA FOOD

Gregory's Foods Cookie Dough Recalled for Undeclared Peanuts

Gregory's Foods recalled 308 cases of White Chocolate Macadamia Nut frozen cookie dough on December 19, 2025. The product contains undeclared peanuts, posing a serious allergy risk. Consumers should not consume the product and seek refunds.

Gregory's Foods
Undeclared peanuts.
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls Stent System Due to Deployment Issues

Boston Scientific recalled 150 units of its *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. The recall follows increased reports of stent deployment and expansion issues, which could lead to serious medical interventions. Healthcare providers and patients must stop using the device immediately.

Boston Scientific
Increased reports
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Health & Personal Care
HIGH
FDA DEVICE

Canon Medical Recalls MRI Systems Over High-Pressure Hazard

Canon Medical Systems recalled 22 MRI systems on December 19, 2025, due to a potential ice formation hazard in the venting system. The defect could lead to a pressure build-up and helium gas release. Healthcare providers must stop using the affected devices immediately.

Canon Medical System, USA
There is
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Health & Personal Care
HIGH
FDA DEVICE

Canon Medical MRI Systems Recalled Over High-Pressure Risk

Canon Medical Systems recalled 34 MRI systems due to a risk of helium gas release. The recall affects models MRT-3020 and MEXL-3020 distributed across 13 states. Healthcare providers should stop using these devices immediately and follow recall instructions.

Canon Medical System, USA
There is
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls AXIOS Stent Due to Deployment Risks

Boston Scientific recalled 557 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. Increased reports of stent deployment and expansion issues prompted this recall. The defect may require additional medical intervention to resolve deployment failures.

Boston Scientific
Increased reports
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Health & Personal Care
HIGH
FDA DEVICE

Canon Medical System Recalls Interventional X-Ray Systems Over Safety Risk

Canon Medical System, USA recalled 332 units of the Alphenix INFX-8000V X-ray system on December 19, 2025. Loose fixing screws may hinder ceiling movement and cause sensor errors. Healthcare providers must stop using the device immediately and follow manufacturer's instructions.

Canon Medical System, USA
It has
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Stent Recalled Over Deployment Issues

Boston Scientific recalled 59 AXIOS Stents on December 19, 2025. Increased reports of deployment and expansion issues pose serious risks during procedures. Users should stop using the devices immediately and follow recall instructions.

Boston Scientific
Increased reports
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Health & Personal Care
HIGH
FDA DEVICE

Wondfo Streptococcal A At-Home Self-Test Recalled for FDA Clearance Issues (2026)

Wondfo recalled 188 units of Streptococcal A At-Home Self-Test sold nationwide in the United States after regulators found the device was not FDA-cleared. The recall centers on lack of FDA clearance for safety and effectiveness. Consumers should stop using the test immediately and contact Altruan GmbH or their healthcare provider for instructions.

Wondfo
Product not
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Health & Personal Care
HIGH
FDA DEVICE

Altruan GmbH Clearest Strep-A Cassette Test Recall 188 Units (2025)

Altruan GmbH recalled 188 units of the Clearest Strep-A Cassette Test distributed nationwide in the United States after determining the device was not cleared by the FDA. The test lacks FDA clearance. Healthcare providers and patients should stop using the test immediately and follow the manufacturer’s recall instructions.

Altruan
Product not
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Health & Personal Care
HIGH
FDA DRUG

Sato Pharmaceutical Recalls INON ACE Antacid Tablets for Disintegration Issues

Sato Pharmaceutical Co., Ltd. recalled 3,640 bottles of INON ACE Antacid tablets on December 19, 2025. The recall follows failed disintegration specifications, indicating the tablets may not dissolve properly. Consumers should stop using the product immediately and seek guidance from healthcare providers.

INON ACE
Failed Disintegration
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Issues Recall for Stent Due to Deployment Issues

Boston Scientific recalled 588 units of its *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. The recall follows multiple reports of stent deployment and expansion issues, posing serious risks during medical procedures.

Boston Scientific
Increased reports
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Health & Personal Care
HIGH
FDA DEVICE

Canon Medical Recalls Interventional X-Ray System Over Safety Risk

Canon Medical System, USA recalled 3 interventional fluoroscopic x-ray systems on December 19, 2025. The recall follows reports that fixing screws in the ceiling movement gear may become loose, causing operational failures. Users should stop using the device immediately and follow provided instructions.

Canon Medical System, USA
It has
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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical Solutions Recalling CT Software Over Clearance Issues

Siemens Medical Solutions USA recalled two units of its NAEOTOM Alpha.Pro software applications on December 19, 2025. The recall affects software used in CT systems that lack FDA 510(k) clearance. Healthcare providers and patients must stop using the software immediately.

Siemens Medical Solutions USA
To remove
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Health & Personal Care
HIGH
FDA DEVICE

Canon Medical Recalls Interventional X-ray System Over Safety Hazard

Canon Medical System, USA recalled 98 units of its Alphenix INFX-8000F X-ray system on December 19, 2025. Loose fixing screws in the ceiling movement gear may cause malfunction and abnormal noise. Healthcare providers should stop using the system immediately and follow recall instructions.

Canon Medical System, USA
It has
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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical Recalls Software Due to Lack of FDA Clearance

Siemens Medical Solutions recalled software applications for certain CT systems on December 19, 2025. The applications did not receive FDA 510(k) clearance. Five units distributed worldwide are affected by this recall.

Siemens Medical Solutions USA
To remove
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Health & Personal Care
HIGH
FDA DEVICE

Tyber Medical Recalls VOLT Wrist Treatment System Due to Hazard

Tyber Medical recalled 100 units of its VOLT Wrist Treatment System on December 19, 2025. The recall stems from a manufacturing defect that affects the thread orientation of anatomical left plates. Healthcare providers and patients should stop using the device immediately.

Tyber Medical
The supplier
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls AXIOS Stent Over Deployment Issues

Boston Scientific recalled 39 AXIOS Stent and Electrocautery-Enhanced Delivery Systems on December 19, 2025. Reports indicated issues with stent deployment and expansion, potentially leading to additional surgical interventions. The recall affects units distributed worldwide, including the United States and several other countries.

Boston Scientific
Increased reports
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Health & Personal Care
HIGH
FDA DEVICE

Rifton Equipment Recalls Low Base TRAM Due to Fraying Hazard

Rifton Equipment recalled 1,096 units of the Low Base TRAM on December 18, 2025, due to a potential fraying hazard on the body support strap. The recall affects models distributed worldwide, including the US, Canada, and several countries in Europe and Asia. Patients and healthcare providers are advised to stop using this device immediately.

Community Products
Potential for
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Health & Personal Care
HIGH
FDA DRUG

Imprimis NJOF Recalls Intraocular Injection Over Glass Particles

Imprimis NJOF, LLC recalled 314 boxes of Tri-Moxi+¿ intraocular injections on December 18, 2025. The recall is due to the presence of glass-like particles in the product. Consumers and healthcare providers should stop using the product immediately and contact the company for further guidance.

Imprimis NJOF
Presence of
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Food & Beverages
HIGH
FDA FOOD

CATAO MARKET Recalls Cuban Loaf Cake Over Undeclared Color Additive

CATAO MARKET recalled 520 master cases of its Authentic Cuban Loaf Cake Raisins on December 18, 2025. The recall occurred due to undeclared FD&C Yellow #5, which poses a high allergy risk. The affected products were distributed only in Florida and have best by dates from December 18, 2025, to March 18, 2026.

CATAO MARKET
Undeclared colors
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