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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Steris recalled 10 units of the Barco MNA with HexaVue IP Integration System on May 23, 2025. A manufacturing error used an incorrect configuration file in a limited batch of adapter components. The recall is classified as Class II and affects states including Florida and Texas.
Medtronic MiniMed recalled 1,440 Simplera Sensor units distributed outside the United States after a device cap label may not adhere, risking sterility. The defect could increase infection risk. Patients and healthcare providers should stop using the device and follow recall instructions provided by Medtronic MiniMed or their healthcare provider.
3M recalled 530,470 Ranger Blood/Fluid Warming High Flow Sets due to incorrect flow rates and outlet temperature locations. This defect can affect the warming of fluids, posing serious risks to patients. Healthcare providers must stop using these devices immediately and follow the manufacturer’s instructions for returns.
ESAOTE recalled 5 Endocavity Ultrasonic Probe E 3-12 units sold in the United States to healthcare providers in NC and TX. A potential weakness in the probe body could cause liquid to leak from the terminal part of the casing near the cable. Healthcare providers and patients should stop using the device immediately and follow manufacturer instructions.
World Perfumes Inc. recalled 3,900 bottles of Iodo Blanco Iodides First Aid Antiseptic in Florida after broken or leaking containers were reported. The recall covers iodine 2% antiseptic distributed by Essential Products. Consumers should stop use immediately and contact World Perfumes or a healthcare provider for guidance.
MEDITECH released an active recall for the Expanse Laboratory calculator/data processing module. The recall covers 148 units distributed worldwide, including the US, UK, Canada, Ireland and the British Virgin Islands. The hazard concerns simultaneous multi-key inputs potentially removing data from the first field in screens or questionnaires.
CorNeat Vision recalled EverPatch surgical matrix (REF 1036295) in a worldwide distribution that includes 50 states and several countries. The recall addresses retroactive labeling corrections to include prevention and management of would dehiscence. Healthcare providers and patients should stop using the device and follow the manufacturer's recall instructions.
Olympus Corporation of the Americas recalled 633 units of the Cystoscope Outer Sheath, Model WA22810A on September 13, 2024. The recall occurred due to potential device damage when used with a GreenLight Laser for BPH therapy. Healthcare providers and patients must stop using the device immediately and follow recall instructions.
Intuitive Surgical recalled 144 units of the da Vinci 5 Surgeon Console Column Motor Connector on August 21, 2024. Users reported a potential ergonomic lock issue that could delay or abort surgical procedures. Healthcare providers must stop using the devices immediately and follow the recall instructions.
Omnia Medical recalled 15 units of the TiBrid Stand Alone Intervertebral Body Fusion Device SA Angled Punch Awl. The recall covers models 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5 with UDI 00843511113056 and 00843511122287/22294. The hazard is failure of fusion system instruments in the field. Consumers should stop use and follow recall instructions.
Omnia Medical issued a recall for 15 units of the TiBrid Stand Alone Intervertebral Body Fusion Device and TiBrid SA Angled Screwdrivers after field failures were reported. The recall covers nationwide distribution in AZ, CA, NJ, NV, OK and WA. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.
Olympus Corporation recalled 3,361 Single Use Electrosurgical Knives on February 17, 2024, due to burn risks from tip breakage. The recall affects model KD-645L, distributed nationwide. The defective knives may overheat and deteriorate during use, posing serious safety risks.
Olympus Corporation of the Americas recalled the Single Use Electrosurgical Knife KD-640L on February 17, 2024. The recall follows reports of overheating and potential tip breakage during surgery. Healthcare providers and patients must stop using the device immediately to avoid injuries.
NOXBOX LTD recalls 1,667 NOxBOXi Nitric Oxide Delivery Systems distributed nationwide in the United States, including Tennessee. The recall centers on replacing the internal Sample Pump due to high failure rates. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions for recall remediation.
Surepulse Medical recalled the VS Cap Small component of its newborn heart rate monitor on January 20, 2023. The recall stems from incorrect sizing information provided on the product label. This defect poses a significant risk to patient safety.
Surepulse Medical recalled its VS Cap Large component for the newborn heart rate monitor on January 20, 2023. The recall addresses an incorrect sizing guide that could affect patient safety. This recall impacts distribution in the US and several countries including the UK and UAE.
Surepulse Medical recalled the Extra Large VS Cap component of its newborn heart rate monitor on January 20, 2023. The recall followed reports of incorrect sizing information that could impact device use. This recall affects distribution in the U.S., the U.K., the Netherlands, and the United Arab Emirates.
Surepulse Medical recalled its VS Cap Extra Small component of the VS Newborn Heart Rate Monitor on January 20, 2023. The recall affects devices distributed in the US and several other countries due to an incorrect sizing guide. Consumers must stop using the device immediately and follow manufacturer instructions.
Surepulse Medical recalled a component of its newborn heart rate monitor on January 20, 2023. The recall affects the VS Cap Medium REF: SP-161-A1 due to incorrect sizing information on the label. This issue poses a high risk to patients and healthcare providers using the device.
Foundation Medicine issued a recall affecting 18 FoundationOne Liquid CDx tests, including 17 in the United States and 1 overseas. The defect is the absence of the companion diagnostic CDx Claims Page in reports. Amended claims pages were distributed within seven days. Stop use immediately and follow manufacturer instructions.
Foundation Medicine recalled 59 units of FoundationOne CDx (F1CDx), RAL-0003 version 31.0 after reports indicated the companion diagnostic Claims Page was omitted. This oversight could impact patient care and healthcare provider decisions concerning diagnosis and treatment. Users should stop using the device and contact Foundation Medicine or their healthcare provider for further instructions.
Philips recalled 1,721 EPIQ Ultrasound Systems on July 14, 2022. The ultrasound may unexpectedly reboot, damaging the transducer. Healthcare providers must stop using the device immediately.
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