Drug Recalls Center

1,425 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.

1,425
Total Drug Recalls
24
High Risk Medications
FDA
Official Source

Important Medication Safety Information

  • Do not stop taking prescribed medications without consulting your healthcare provider
  • Contact your pharmacist or doctor if you have a recalled medication
  • Check lot numbers carefully - not all batches may be affected
  • Return recalled medications to your pharmacy for proper disposal

Looking for a specific drug? Use the search page to find recalls by medication name, manufacturer, or NDC number.

HIGHFDA DEVICE

Merit Medical Recalls Vascular Tray Over Detaching Handle Hazard

Merit Medical Systems recalled 864 units of its Custom Waste Management Kit Vascular Tray on December 4, 2025. The handle of the inflation device may detach from the syringe during use, posing a serious risk to patients. Healthcare providers should stop using the device immediately and follow recall instructions.

Merit Medical Systems
Inflation device
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HIGHFDA DEVICE

Merit Medical Recalls Inflation Kits Due to Handle Detachment Hazard

Merit Medical Systems recalled 18,897 custom inflation kits on December 4, 2025. The inflation device handle may detach from the syringe during use, posing a risk of injury. Healthcare providers and patients should stop using the device immediately.

Merit Medical Systems
Inflation device
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HIGHFDA DEVICE

Medtronic Recalls Stent System Due to Migration Risk

Medtronic recalled its Abre Venous Self-Expanding Stent System on December 4, 2025, due to a potential Nitinol anomaly. This issue may lead to reduced stent diameter and corresponding radial force, increasing the risk of stent migration. The recall affects 442 units distributed worldwide, including the U.S.

Medtronic
Stents may
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HIGHFDA DEVICE

Mobius Imaging Recalls AIRO CT X-ray Pendant Due to Safety Risk

Mobius Imaging recalled 26 units of the Detachable 10in Pendant Upgrade for the AIRO CT X-ray System on December 4, 2025. The devices lack a critical "Safe Hand Position Warning" label, posing a high risk during operation. Healthcare providers and patients must cease use immediately and follow the manufacturer's instructions.

Mobius Imaging
AIRO pendant
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HIGHFDA DEVICE

Merit Medical Inflation Device Recalled Over Handle Detachment Risk

Merit Medical Systems recalled 4,163,123 inflation devices on December 4, 2025, due to a risk that the handle may detach during use. This defect poses a high hazard to patients and healthcare providers. Consumers should stop using the device immediately and follow the manufacturer’s instructions for returns.

Merit Medical Systems
Inflation device
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HIGHFDA DEVICE

Merit Medical Recalls Custom Procedure Kits Due to Detachment Hazard

Merit Medical Systems recalled multiple Custom Procedure Kits on December 4, 2025, due to a risk of the inflation device handle detaching from the syringe during use. The recall affects several reference numbers sold worldwide, including in the U.S. and various international markets.

Merit Medical Systems
Inflation device
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HIGHFDA DEVICE

Merit Medical Systems Recalls Angioplasty Packs Over Detachment Hazard

Merit Medical Systems recalled 328,000 angioplasty packs on December 4, 2025, due to a risk of the inflation device handle detaching during procedures. The recall affects devices distributed worldwide, including states across the U.S. Healthcare providers and patients must stop using the devices immediately.

Merit Medical Systems
Inflation device
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HIGHFDA DEVICE

Intuitive Surgical Recalls Ion Vision Probe Bag Over Sterility Risk

Intuitive Surgical recalled 110,580 Ion Vision Probe Bags on December 4, 2025, due to compromised sterile seals. The recall affects devices distributed throughout the United States and several countries including Australia and Germany. Patients and healthcare providers should stop using the product immediately.

Intuitive Surgical
Due to
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HIGHFDA DEVICE

Boston Scientific Recalls Balloon Catheters Over Inflation Issues

Boston Scientific recalled 21,000 Coyote Over-the-Wire PTA Balloon Dilation Catheters on December 3, 2025. The recall affects devices that may not properly inflate or deflate, posing a risk during medical procedures. Patients and healthcare providers should stop using these devices immediately and follow the recall instructions.

Boston Scientific
Boston Scientific
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HIGHFDA DEVICE

Philips Incisive CT Recalled Over Scan Incompletion Risk

Philips Healthcare recalled 35 Incisive CT scanners on December 3, 2025. The devices may produce incomplete scans due to an unstable connection inside the floating sensor. Healthcare providers must stop using these devices immediately and follow recall instructions.

Philips Healthcare
Potential for
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HIGHFDA DEVICE

Philips MR 7700 Systems Recalled Due to Stiffness Value Errors

Philips North America recalled 9 MR 7700 systems on December 3, 2025, due to potential errors in stiffness maps. The recall affects models with software versions R11.1 and R12.1, posing a high hazard risk. Healthcare providers must stop using these devices immediately and follow manufacturer instructions.

Philips North America
The potential
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HIGHFDA DEVICE

Philips North America Recalls MR Systems Over Stiffness Value Errors

Philips North America recalled one unit of its Evolution Upgrade 3.0T on December 3, 2025, due to potential stiffness value errors in MR Elastography stiffness maps. The issue affects software versions R11.1 and R12.1. Affected units may misrepresent medical imaging data, posing risks to patient diagnoses.

Philips North America
The potential
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HIGHFDA DEVICE

Philips Recalls Ingenia Elition S MR Systems Over Stiffness Errors

Philips North America recalled five Ingenia Elition S MR systems on December 3, 2025. The recall affects systems with software versions R11.1 and R12.1 due to potential errors in stiffness value readings. This issue poses a serious risk to patient safety when interpreting MR Elastography maps.

Philips North America
The potential
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HIGHFDA DEVICE

Philips North America Recalls MR Imaging System Over Stiffness Errors

Philips North America recalled three MR imaging systems on December 3, 2025, due to potential stiffness value errors in exported MR Elastography maps. The systems, identified by product code REF: 781270, have software versions R11.1 and R12.1. Users should stop using the devices immediately and contact their healthcare providers for further instructions.

Philips North America
The potential
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HIGHFDA DEVICE

Philips MRI System Recalled Due to Stiffness Value Errors

Philips North America recalled 31 MRI systems on December 3, 2025, due to potential errors in stiffness value readings. The affected models include product codes 781358, 782107, and 782136 with software versions R11.1 and R12.1. Healthcare providers must stop using these devices immediately to prevent misdiagnosis.

Philips North America
The potential
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HIGHFDA DEVICE

Philips North America Recalls Ingenia 3.0T MR Systems Over High Hazard

Philips North America recalled 24 Ingenia 3.0T MR systems on December 3, 2025, due to potential stiffness value errors in MR Elastography maps. The recall affects systems with software versions R11.1 and R12.1, distributed across multiple states and countries. Healthcare providers must stop using these devices immediately to prevent misdiagnosis.

Philips North America
The potential
Read more
HIGHFDA DEVICE

Philips North America Recalls MR Systems Over Stiffness Value Errors

Philips North America recalled three MR systems on December 3, 2025. The recall affects models with software versions R11.1 and R12.1 due to potential stiffness value errors. Healthcare providers and patients must stop using these devices immediately.

Philips North America
The potential
Read more
HIGHFDA DEVICE

Philips North America Issues Recall of MR Systems Due to High Hazard Risk

Philips North America recalled one unit of its MR system on December 3, 2025, due to potential stiffness value errors in MR Elastography maps. The recall affects systems with software versions R11.1 and R12.1, distributed worldwide. Healthcare providers should stop using the device immediately and follow the manufacturer's instructions.

Philips North America
The potential
Read more
HIGHFDA DEVICE

Philips Recalls Ingenia Ambition S MR Systems Over Stiffness Errors

Philips North America recalled Ingenia Ambition S MR systems on December 3, 2025, due to stiffness value errors in exported MR Elastography maps. The recall affects one unit distributed in multiple U.S. states and several countries. Users must stop using the device immediately and follow recall instructions.

Philips North America
The potential
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HIGHFDA DEVICE

Philips Recalled Ingenia Ambition X MR Systems Over Stiffness Errors

Philips North America recalled 21 Ingenia Ambition X MR systems on December 3, 2025, due to potential stiffness value errors. The recall affects models with software versions R11.1 and R12.1, distributed in the U.S. and worldwide. Healthcare providers must stop using these devices immediately and follow provided instructions.

Philips North America
The potential
Read more
HIGHFDA DEVICE

Philips North America Recalls MR Systems Due to Stiffness Value Errors

Philips North America recalled 6 MR systems on December 3, 2025, due to the potential for stiffness value errors. These errors can occur when viewing exported MR Elastography stiffness maps on Picture Archiving and Communication Systems. Users should stop using the devices immediately and follow recall instructions.

Philips North America
The potential
Read more

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