1,355 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.
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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 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.
Elekta recalled the Leksell GammaPlan RT Treatment Planning System on December 12, 2025, due to a software error. This defect may lead to incorrect patient irradiation if not detected. Healthcare providers must stop using the software immediately.
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.
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.
Instrumentation Laboratory recalled 7,720 coagulation testing devices on December 11, 2025. The recall stems from a potential for microbial contamination. Healthcare providers and patients should stop using the device immediately.
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 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 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 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 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 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 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.
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 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.
REPLIGEN Corporation recalled 33 Maverick Measurement Module Spectrometers on December 10, 2025. Disconnected or poorly crimped cables may cause elevated laser output or unintended firing. The recall affects devices distributed in the U.S.
GE HealthCare recalled 12 Nuclear Medicine systems on December 10, 2025, due to a potential fall hazard. The affected systems may have inadequate support during transport, risking detector integrity. No injuries have been reported, but the risk of life-threatening incidents exists.
Elekta recalled the MOSAIQ Oncology Information System on December 10, 2025. A malfunction may cause overtreatment in patients due to software issues. Healthcare providers should stop using the device immediately and follow recall instructions.
GE Healthcare recalled seven Nuclear Medicine systems on December 10, 2025, due to potential detector falls. The recall affects systems that have exceeded their End of Guaranteed Service. No injuries or falls have been reported.
Mazor Robotics recalled 549 Mazor X robotic guidance systems on December 10, 2025, due to software errors. These errors may cause incorrect surgical instrument positioning during spinal surgeries. Patients and healthcare providers must stop using the device immediately.
Heraeus Medical GmbH recalled PALACOS R+G pro 40 and 80 bone cements on December 9, 2025. The recall follows multiple reports of ampoule breakage that prevent proper use of the product. Patients and healthcare providers must stop using the affected devices immediately.
Heraeus Medical GmbH recalled PALACOS MV+G pro 40 and MV+G pro 80 bone cement on December 9, 2025. The recall follows complaints about ampoule breakage, which can prevent proper cement formation. This issue could jeopardize patient safety during medical procedures.
Heraeus Medical GmbH recalled PALACOS MV pro 40 and MV pro 80 bone cement on December 9, 2025. The recall follows numerous complaints about ampoule breakage. This defect can prevent proper cement dough formation, rendering the product unusable for patients.
Heraeus Medical GmbH recalled PALACOS R pro 40 and R pro 80 bone cement on December 9, 2025. The recall follows multiple complaints of ampoule breakage affecting product usability. Healthcare providers must stop using the product immediately.
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