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

Medline Recalls Medical Kits Over Adhesive Tubing Hazard

Medline Industries recalled 1,928 medical procedure kits due to a safety hazard involving butyrate tubing. The recall affects multiple kit models containing MASTISOL liquid adhesive. The defective tubing may crack during use, posing a risk to patients and healthcare providers.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Medical Kits Recalled Due to Hazardous Adhesive

Medline recalled multiple medical procedure convenience kits on December 12, 2025. The recall affects 66 units containing MASTISOL liquid adhesive. The adhesive's tubing may crack, posing a serious risk during use.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Convenience Kits Recalled Over Adhesive Hazard

Medline Industries recalled select medical procedure convenience kits on December 12, 2025. The recall affects 40 units due to risks associated with MASTISOL liquid adhesive. The adhesive's tubing may crack during use, posing safety concerns.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Circumcision Kits Recalled Over Adhesive Hazard

Medline Industries, LP recalled 1,928 circumcision procedure kits on December 12, 2025. The kits contain MASTISOL liquid adhesive, which may crack during use. Healthcare providers and patients must stop using these kits immediately.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Medical Kits Recalled Due to Liquid Adhesive Hazard

Medline Industries, LP recalled 1,928 medical procedure convenience kits on December 12, 2025. The kits contain MASTISOL liquid adhesive linked to cracking tubing during use. Healthcare providers and patients must stop using these kits immediately.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Medical Kits Recalled Over Hazardous Adhesive

Medline Industries recalled 236 medical procedure kits on December 12, 2025. The kits contain MASTISOL liquid adhesive that may cause butyrate tubing to crack. Patients and healthcare providers should stop using these kits immediately.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Medline Medical Kits Recalled Due to Adhesive Hazard

Medline Industries recalled 1,928 medical procedure convenience kits on December 12, 2025, due to a risk of crack in the adhesive tubing. The kits contain MASTISOL liquid adhesive, leading to safety concerns. Healthcare providers and patients should stop using the kits immediately and follow the recall instructions.

Medline Industries, LP
Medline kits
Read more
HIGHFDA DEVICE

Medline Medical Kits Recalled Due to Cracked Tubing Hazard

Medline Industries, LP recalled 857 medical procedure convenience kits on December 12, 2025. The kits contain MASTISOL liquid adhesive which can cause butyrate tubing to crack during use. Healthcare providers and patients must stop using these kits immediately.

Medline Industries, LP
Medline kits
Read more
HIGHFDA DEVICE

Medline Medical Procedure Kits Recalled Over Adhesive Hazard

Medline Industries recalled 456 medical procedure kits on December 12, 2025, due to a potential hazard involving MASTISOL liquid adhesive. The defective butyrate tubing may crack during use, posing a risk to patients and healthcare providers. Consumers must stop using these kits immediately and seek further instructions.

Medline Industries, LP
Medline kits
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HIGHFDA DEVICE

Elekta Recalls Leksell GammaPlan Software Due to High Radiation Risks

Elekta recalled the Leksell GammaPlan Radionuclide RT Treatment Planning System on December 12, 2025. The software, used for treatment planning, may incorrectly irradiate patient locations due to a stereotactic reference error. This recall affects users worldwide, including in the U.S. and various international locations.

Elekta
Due to
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HIGHFDA DEVICE

Bard Peripheral Vascular Recalls CV Catheter Due to Sterility Risk

Bard Peripheral Vascular Inc. recalled 14,935 units of the Broviac 4.2 Fr Single-Lumen CV Catheter Tray on December 12, 2025. Damage to the outer tray may compromise the sterile barrier, posing a high hazard. Healthcare providers and patients should stop using the device immediately.

Bard Peripheral Vascular
Due to
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HIGHFDA DEVICE

Applied Medical Resources Recalls Cannula Due to Blade Hazard

Applied Medical Resources recalled 450 units of the Kii Low Profile, Bladed Dual Pack on December 11, 2025, due to a potential safety issue. The blade obturator may extend beyond safe limits after assembly, posing a risk to patients. Healthcare providers and patients should stop using the device immediately.

Applied Medical Resources
There is
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HIGHFDA DEVICE

Fujirebio Diagnostics Recalls Lumipulse ¿-Amyloid Controls Over Test Inaccuracy

Fujirebio Diagnostics recalled 179 units of Lumipulse ¿-Amyloid Plasma Controls on December 11, 2025. The recall stems from inaccurate test results leading to potential misclassification of Alzheimer's disease. Customers should stop using the device immediately and follow the manufacturer's instructions.

Fujirebio Diagnostics
Customers may
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HIGHFDA DEVICE

Fujirebio Diagnostics Issues Recall for Inaccurate Test Results

Fujirebio Diagnostics recalled 1,423 units of Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges on December 11, 2025. The recall affects models found to provide inaccurate test results, potentially misclassifying Alzheimer's disease. Healthcare providers and patients should stop using these cartridges immediately.

Fujirebio Diagnostics
Customers may
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HIGHFDA DEVICE

Fujirebio Diagnostics Recalls Diagnostic Test Over Inaccurate Results

Fujirebio Diagnostics recalled 23 units of its Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio test on December 11, 2025. The recall follows concerns that the product may produce inaccurate test results, potentially misclassifying patients with Alzheimer's disease. Healthcare providers should stop using this device immediately and follow recall instructions.

Fujirebio Diagnostics
Customers may
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HIGHFDA DEVICE

Fujirebio Diagnostics Recalls Plasma Calibrators Over Inaccurate Results

Fujirebio Diagnostics recalled 128 units of Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators on December 11, 2025. The recall stems from the risk of inaccurate test results leading to misclassification of Alzheimer’s disease. Affected products may cause patients to receive unnecessary additional clinical testing.

Fujirebio Diagnostics
Customers may
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HIGHFDA DEVICE

Fujirebio Diagnostics Recalled pTau 217 Plasma Cartridges

Fujirebio Diagnostics recalled 1,569 units of Lumipulse G pTau 217 Plasma Immunoreaction Cartridges on December 11, 2025. The recall affects users due to potential inaccurate test results associated with Alzheimer's disease classifications. Customers in 13 states should stop using the product immediately.

Fujirebio Diagnostics
Customers may
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HIGHFDA DEVICE

Fujirebio Diagnostics Recalls Lumipulse pTau 217 Plasma Controls Due to High Risk of Inaccurate Test

Fujirebio Diagnostics recalled 148 units of Lumipulse pTau 217 Plasma Controls on December 11, 2025. The recall follows reports of inaccurate test results that misclassify patients regarding Alzheimer’s disease. The affected product may falsely elevate positive or indeterminate results, increasing the risk of incorrect patient classification.

Fujirebio Diagnostics
Customers may
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HIGHFDA DEVICE

Fujirebio Diagnostics Recalls Lumipulse G pTau 217 Plasma Calibrators

Fujirebio Diagnostics has recalled 117 units of Lumipulse G pTau 217 Plasma Calibrators due to inaccurate test results. The recall was announced on December 11, 2025, after customers reported false classifications of Alzheimer’s disease. Affected products were distributed nationwide, including in states like California and Florida.

Fujirebio Diagnostics
Customers may
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HIGHFDA DEVICE

GE HealthCare Recalls Nuclear Medicine Systems Over Fall Risk

GE HealthCare recalled 38 Nuclear Medicine systems on December 10, 2025, due to potential detector falls. The affected systems may have been relocated without adequate support, risking serious injury. No incidents have been reported, but the recall is classified as a Class II hazard.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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HIGHFDA DEVICE

GE HealthCare Recalls Nuclear Medicine Systems Over Fall Risk

GE HealthCare recalled three Nuclear Medicine systems on December 10, 2025. The recall follows concerns over inadequate detector support, which could lead to a fall and serious injury. No incidents have been reported to date.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare
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