Drug Recalls Center

1,355 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.

1,355
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

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
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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
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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
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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
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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
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HIGHFDA DEVICE

Philips Ingenia 1.5T MR Systems Recalled Over Stiffness Value Errors

Philips North America recalled 10 Ingenia 1.5T MR systems on December 3, 2025, due to potential stiffness value errors. The affected models include Product Codes 781341 and 781396 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

Zimmer Recalls Affixus Femoral Nails Over Fatigue Fracture Risk

Zimmer, Inc. recalled 23 Affixus Antegrade Femoral Nails on December 2, 2025. These implants may have an undersized distal diameter that could lead to fatigue fractures. Patients should stop using the device immediately and contact their healthcare provider.

Zimmer
Affected implants
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HIGHFDA DEVICE

Microbiologics Recalls LYFO DISK Due to Testing Failure Risk

Microbiologics recalled LYFO DISK, Catalog Number 0325L, on December 2, 2025, after reports indicated affected units may fail to recover Campylobacter jejuni. This recall affects one unit, with an additional 16 units added on December 22, 2025. The recall impacts products distributed worldwide, including the United States.

Microbiologics
Affected units
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HIGHFDA DEVICE

Zimmer Recalls Affixus Femoral Nails Over Fracture Risk

Zimmer Inc. recalled 24 units of Affixus Antegrade Femoral Nails on December 2, 2025. The recall follows reports of undersized distal diameters that could lead to implant fatigue fractures. This defect poses a high risk of adverse tissue reactions and requires immediate action.

Zimmer
Affected implants
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HIGHFDA DEVICE

Zimmer Recalls Affixus Antegrade Femoral Nails Due to Fracture Risk

Zimmer recalled 24 Affixus Antegrade Femoral Nails on December 2, 2025, due to potential implant fatigue fractures. The defective implants could cause severe health risks, including pain, tissue damage, and the need for additional surgery. Healthcare providers and patients must cease use immediately and follow recall protocols.

Zimmer
Affected implants
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HIGHFDA DEVICE

Affixus Antegrade Femoral Nailing System Recalled Over Fracture Risk

Zimmer Inc. recalled 24 units of the Affixus Antegrade Femoral Nailing System on December 2, 2025. Affected implants may have an undersized distal diameter that could lead to implant fatigue fractures. Risks include pain, tissue damage, and potential surgical intervention.

Zimmer
Affected implants
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HIGHFDA DEVICE

Zimmer Recalls Affixus Femoral Nails Due to Fracture Risk

Zimmer, Inc. recalled 11 units of the Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may have an undersized distal diameter, posing a risk of fatigue fracture. This defect could cause adverse reactions requiring surgical intervention.

Zimmer
Affected implants
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