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

2,324 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 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.
Read more
HIGHFDA DEVICE

ICU Medical Recalls Spinal Tray Syringes Due to Leakage Risk

ICU Medical recalled 64,290 spinal tray syringes on December 19, 2025, due to potential cracks in the syringe collar. The cracks may cause blood leakage and delays in blood draws or fluid delivery. Affected syringes were distributed nationwide across 13 states.

ICU Medical
Affected lots
Read more
HIGHFDA 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
Read more
HIGHFDA 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
Read more
HIGHFDA 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
Read more
HIGHFDA FOOD

Troemner Farm Recalls Cookies Over Undeclared Allergens

Troemner Family Farm recalled 56 units of Pfeffernusse Cookies on December 19, 2025, due to undeclared allergens. The cookies contain soy, wheat, and milk, posing a serious risk to consumers with allergies. The affected products were distributed in Michigan.

Troemner Farm
undeclared soy,
Read more
HIGHFDA DEVICE

ICU Medical Recalls Needles Free Access Devices Due to High Risk of Leakage

ICU Medical has recalled over 14 million needle-free access devices after reports of fluid leaks and potential exposure to biological contaminants. The recall affects devices distributed worldwide, including in 50 states and multiple countries. Users must stop using these devices immediately and follow recall instructions from the manufacturer.

ICU Medical
Needle free
Read more
HIGHFDA DEVICE

Tyber Medical Recalls VOLT Wrist Treatment System Over Thread Issue

Tyber Medical recalled 64 units of the VOLT Wrist Treatment System on December 19, 2025. The recall affects model number 02.426.691S due to incorrect thread orientation in anatomical left plates. Patients and healthcare providers should stop using this device immediately.

Tyber Medical
The supplier
Read more
HIGHFDA DEVICE

MicroPort Recalls HIPTURN Fem Head Trial Device Over FDA Violation

MicroPort Orthopedics recalled 91 units of the HIPTURN Fem Head Trial 36mm Reusable device on December 19, 2025. The recall follows the lack of FDA premarket authorization for distribution in the United States. The affected devices were distributed across multiple states and several countries, posing a potential health risk to patients and healthcare providers.

MicroPort Orthopedics
Due to
Read more
HIGHFDA 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
Read more
HIGHFDA DEVICE

Canon Medical Recalls Alphenix INFX-8000C X-Ray System Over Safety Risk

Canon Medical System, USA recalled 172 Alphenix INFX-8000C x-ray systems on December 19, 2025, due to loose screws in the ceiling movement gear. This defect can lead to loss of lateral movement, abnormal noise, and sensor errors. Healthcare providers must stop using the device immediately.

Canon Medical System, USA
It has
Read more
HIGHFDA 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
Read more
HIGHFDA 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
Read more
HIGHFDA 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
Read more
HIGHFDA 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
Read more
HIGHFDA 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
Read more
HIGHFDA DEVICE

Siemens Medical Recalls CT Software Over FDA Clearance Issues

Siemens Medical Solutions USA recalled two units of its CT software applications on December 19, 2025. The software lacks FDA 510(k) clearance, posing potential risks to patients. Healthcare providers should stop using the affected software immediately.

Siemens Medical Solutions USA
To remove
Read more
HIGHFDA DEVICE

Tornier Recalls Surgical Screws Over Labeling Error

Tornier recalled 427 units of its Perform Reversed Perip Screws on December 19, 2025, due to incorrect labeling. The screws, meant to be 5.0mmx18mm, were misidentified as 5.00mmx14mm. This labeling issue can lead to surgical delays or increased risk of mechanical failure if unnoticed.

Tornier
A specific
Read more
HIGHFDA 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
Read more
HIGHFDA 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
Read more
Advertisement