1,894 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 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.
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 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.
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.
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.
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 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 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 1,569 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.
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.
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.
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 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.
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 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.
Intuitive Surgical recalled 2,095 units of the da Vinci S, Si EndoWrist Tenaculum Forceps Instrument distributed nationwide in the United States and in multiple countries after reports of frayed or broken pitch cables. The defect can compromise instrument control during surgery. Hospitals and surgeons should stop using the device immediately and follow recall instructions from Intuitive Surgical.
Intuitive Surgical recalled 2,660 da Vinci S/Si Grasping Retractor Instruments worldwide after increased complaints of broken or frayed grip cables. The devices transmit motion from input disks to the distal tip and are used in robotic surgery. Hospitals and surgical centers should stop using the device immediately and follow recall instructions from the manufacturer.
Intuitive Surgical recalled 2,370 units of the da Vinci S, Si Double Fenestrated Grasper Instrument distributed worldwide on December 9, 2025. The EndoWrist instruments use mechanical cables to transmit motion. Healthcare facilities should stop using the devices and follow the manufacturer’s recall instructions.
Intuitive Surgical recalled 6,152 da Vinci S, Si Permanent Cautery Hook Instruments distributed to U.S. hospitals and clinics overseas. The defect involves frayed or broken pitch cables. Healthcare facilities should stop using the instruments immediately and follow manufacturer recall instructions. If you operate with these tools, consult your supplier or Intuitive Surgical for next steps.
Intuitive Surgical recalled 86,904 da Vinci S and Si Monopolar Curved Scissors instruments sold worldwide to hospitals and surgical centers. The recall cites increased complaints of broken or frayed grip cables on reusable instruments. Healthcare facilities should stop using the device immediately and follow the manufacturer’s recall instructions.
Intuitive Surgical recalled 7,819 units of the da Vinci S/Si Mega Needle Driver Instrument sold worldwide to hospitals and healthcare providers. The recall cites broken or frayed grip cables that can impair instrument control. Stop using the device and follow the manufacturer’s recall instructions for replacement or service.
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.
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