1,355 pharmaceutical and medication recalls tracked. Stay informed about FDA drug safety alerts, prescription medications, over-the-counter drugs, and dietary supplements.
Looking for a specific drug? Use the search page to find recalls by medication name, manufacturer, or NDC number.
Securitas Healthcare recalled 5,627 Arial 900 MHz Call Stations on December 8, 2025. A firmware issue may prevent low battery alerts from being transmitted, posing a risk. Affected devices were sold worldwide, including the US and Canada.
Securitas Healthcare recalled 1,898 units of the Arial 900 MHz Call Station on December 8, 2025. A firmware issue may prevent low battery alerts, posing a risk of battery failure. Users should stop using the device immediately and follow recall instructions.
IMRIS Imaging recalled 122 Head Fixation Devices on December 8, 2025. A torque screw may crack or separate, posing serious risks during surgical procedures. Healthcare providers must stop using the device and follow recall instructions immediately.
ORL Labs recalled 1,458 containers of ORL Kids Natural Toothpaste, Bubblegum Flavor, on December 8, 2025. The recall follows cGMP deviations that could pose health risks. Consumers should stop using the product immediately.
Beckman Coulter recalled 34,451 units of its LDL Cholesterol OSR6x96 assay on December 8, 2025, due to significant performance interference. The recall affects multiple states in the U.S. and several countries internationally. Affected products may provide inaccurate LDL cholesterol readings, posing health risks to patients.
ORL Labs, LLC recalled 570 bottles of ORL Kids Mouthwash, Bubblegum Flavor on December 8, 2025. The recall stems from violations of current Good Manufacturing Practices (cGMP). The product was distributed only in Arizona and poses potential safety risks for children.
Philips recalled 990 Azurion Systems on December 8, 2025, after nine software issues were identified. The defects may cause loss of X-ray functionality, system restarts, and other operational failures. Healthcare providers must stop using the devices immediately.
Beaver-Visitec International recalled five units of the OME6000U Laser and Endoscopy System on December 5, 2025. The recall stems from a manufacturing deviation where ferrites required for the USB cable were not installed. This omission poses a high electrical hazard risk to patients and healthcare providers.
Meridian Bioscience recalled 211 units of the Revogene C. difficile diagnostic assay on December 5, 2025. Users may experience false-negative results due to a decline in performance over time. Patients and healthcare providers must stop using the device immediately.
Siemens Medical Solutions USA recalled LUMINOS Lotus Max and Luminos dRF Max systems on December 5, 2025. The recall affects systems with software version VF11 and involves a potential collimation error. Healthcare providers and patients must stop using the devices immediately.
LimFlow recalled 33 units of its Vector model VT-US-23 on December 5, 2025, due to incorrect expiration dates. Patients and healthcare providers should stop using this device immediately. The recall affects distribution across 14 states and the District of Columbia.
Abiomed recalled two units of the Impella 5.5 with SmartAssist on December 4, 2025. The devices were packaged in incorrect outer cartons, posing a potential hazard. Patients and healthcare providers must stop using the devices immediately.
Mobius Imaging recalled 101 units of the AIRO Computed Tomography X-ray system pendant on December 4, 2025. The pendants lack a critical "Safe Hand Position Warning" label, posing a safety risk for healthcare providers. Users should immediately stop using these devices and follow recall instructions.
Merit Medical Systems recalled 173,645 Allwell Inflation Devices on December 4, 2025. The device handle may detach from the syringe during procedures, posing a high hazard. Healthcare providers and patients should stop using the device immediately.
Merit Medical Systems recalled 2,192 units of its Custom Manifold Kit on December 4, 2025. The inflation device handle may detach from the syringe during procedures. This poses a significant risk to patients and healthcare providers.
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 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.
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.
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.
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 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 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.
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.
Medtronic Neuromodulation recalled 7,123 units of the Vanta Clinician Programmer Application on December 3, 2025. The software may not function as intended, potentially delaying surgical procedures. Healthcare providers and patients must stop using the software immediately.
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