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

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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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HIGHFDA 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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HIGHFDA DEVICE

Siemens Medical Recalls NAEOTOM Alpha CT Software Over FDA Clearance Issue

Siemens Medical Solutions USA, Inc. recalled 88 units of NAEOTOM Alpha software applications on December 19, 2025. The applications lack FDA 510(k) clearance, posing potential risks to patient safety. Healthcare providers must stop using the software immediately and follow the manufacturer's instructions.

Siemens Medical Solutions USA
To remove
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HIGHFDA 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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HIGHFDA DEVICE

Boston Scientific Recalls HOT AXIOS Stent Over Deployment Issues

Boston Scientific recalled 266 units of the HOT AXIOS Stent on December 19, 2025. Reports indicated deployment and expansion problems, posing risks of prolonged procedures and additional surgical interventions. Consumers must stop using the device immediately and follow the manufacturer's instructions.

Boston Scientific
Increased reports
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HIGHFDA 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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Recalled Meaicezli Play Purse Set Packaging
HIGH
CPSC

Meaicezli Play Purse Sets Recalled Over Battery Ingestion Risk

Meaicezli recalled Play Purse Sets on December 18, 2025, due to a risk of serious injury from battery ingestion. The toys contain button cell and lithium coin batteries accessible to children. Consumers must stop using the products and return them for a full refund.

Meaicezli
The children's
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HIGHFDA 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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