1,264 recalls tagged with “fda regulated”.
Baxter Healthcare recalled 15,552 CLEARLINK SYSTEM EXTENSION SETS nationwide in the United States. The IV extension sets may leak. Healthcare providers and patients should stop using the device immediately and follow Baxter recall instructions.
Northeast Scientific recalled 561 units of NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. The recall covers all lots within shelf life ending before August 29, 2026. The hazard is breaches in sterile barrier packaging that could compromise sterility. Stop using the device and follow manufacturer instructions for return or replacement.
Granules Pharmaceuticals recalled 9,917 bottles of mixed-salts amphetamine extended-release capsules nationwide. The recall was issued August 28, 2025 and remains active. The FDA cited failed impurities/degradation specifications as the reason. Healthcare providers and consumers should stop using the product immediately and contact Granules Pharmaceuticals for guidance.
Granules Pharmaceuticals recalled 11,928 bottles of an extended-release amphetamine product. The recall date is 2025-08-28 for Dextroamphetamine saccharate and related salts. The FDA lists the reason as failed impurities and degradation specifications. The recall remains active as of 2025-10-01. Health care providers and patients should stop use and contact the manufacturer for guidance.
Ascend Laboratories, LLC recalls 2,256 bottles of ARIPIPRAZOLE 10 mg tablets distributed nationwide after discovering the product to be superpotent. The recall involves ARIPIPRAZOLE tablets manufactured by Alken Laboratories Ltd. in India and distributed in the United States. The recall date is August 28, 2025, with consumer notification by letter and guidance to stop use.
Granules Pharmaceuticals recalled 11,895 bottles of an extended-release amphetamine product due to failed impurities and degradation specifications. The recall is active nationwide in the United States. The FDA notice lists a high hazard level and urges stop-use and contact with the company or a healthcare provider.
Granules Pharmaceuticals recalled 11,909 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules sold nationwide to pharmacies and health care providers. The recall stems from a failure to meet impurities and degradation specifications. Patients taking this prescription should stop using the product and
Boston Scientific recalled 156 units of the Extractor Pro RX Retrieval Balloon Catheter nationwide in the United States after labeling inconsistencies were found. The label misstates whether the skive hole is above or below the balloon. The recall is active as of 2025. Stop using the device immediately and follow manufacturer instructions.
Granules Pharmaceuticals Inc. recalls 3,384 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, 100 capsules per bottle, NDC 70010-029-01, Lot GPC250158A, Exp 06-22-2027. The recall concerns failed impurities/degradation specifications. Healthcare providers and consumers should stop using the
Siemens Medical Solutions USA issued a global recall for the MAGNETOM Connectom.X MRI system, Model 11371480. One unit is affected. A potential ice blockage in the magnet venting system could cause a helium leak during a quench. Users should stop using the device and await manufacturer instructions.
Siemens Medical Solutions USA issued an active recall for 1 unit of the BIOGRAPH One MRI System. The recall cites ice blockage in the magnet venting system that could prevent helium from escaping during a quench, risking rupture and helium leakage into the scanning room. Healthcare providers should follow the manufacturer’s recall instructions immediately.
Siemens Medical Solutions USA recalled 30 MAGNETOM Skyra fit MRI units worldwide after identifying an ice blockage in the magnet venting system. The defect could prevent helium venting during a quench, causing pressure buildup that may rupture the helium containment and leak into the scanning room. Hospitals should stop using the affected devices immediately and follow the manufacturer’s recall,咨询
Siemens Medical Solutions USA recalled 39 MAGNETOM Prisma MRI systems sold worldwide to healthcare providers. A potential ice blockage in the magnet venting system could prevent helium gas from escaping during a quench, causing pressure to build and potentially rupture the helium containment system. Hospitals and imaging centers using MAGNETOM Prisma should stop using the devices immediately and,,
Siemens Medical Solutions USA recalled 30 MAGNETOM Verio Dot MRI systems sold worldwide through hospitals and medical facilities. The ice blockage in the magnet venting system could trap helium during a quench, causing pressure buildup and a potential helium leak into the scanning room. Facilities should stop using the devices immediately and follow the manufacturer’s recall instructions.
Siemens Medical Solutions USA recalled 23 Biograph mMR PET-MRI systems worldwide after detecting an ice blockage in the magnet venting system. In a magnet quench, helium gas may not escape through vent paths, risking rupture of the helium containment and a leak into the scanning room. Hospitals and providers must stop using the device immediately and follow the manufacturer’s recall instructions.
Siemens Medical Solutions USA recalls 18 MAGNETOM Skyra Fit BioMatrix MRI systems worldwide due to ice blockage in the magnet venting system that could trap helium gas during a quench. The risk is a ruptured helium containment and a potential helium leak into the scanning room. Hospitals and clinicians should stop using the affected devices and await manufacturer instructions.
Siemens Medical Solutions USA recalls 69 MAGNETOM Verio MRIs worldwide after an ice blockage could trap helium gas during a quench. A rupture of the helium containment system may leak helium into the scanning room. The recall affects models with number 10276755 and serials including 40649 and others. Patients and providers should stop using the device and follow manufacturer instructions.
Siemens Medical Solutions USA recalls MAGNETOM Spectra MRI with Model Number 10655588 after possible ice blockage in the magnet venting system could cause a helium leak during a quench. The recall covers worldwide distribution including the United States. Patients should stop using the device and follow manufacturer instructions for recall procedures.
Siemens Medical Solutions USA recalled 237 MAGNETOM Vida MRI scanners sold worldwide to healthcare providers. The recall cites ice forming in the magnet venting system. A quench could lead to a helium leak into the scanning room. Hospitals must stop using the devices and await manufacturer instructions.
Green Lumber Holdings recalled its Natural Fuel For Men capsules on August 28, 2025. The FDA found the capsules contain tadalafil, a prescription ingredient not approved for this product. Consumers should stop using the product immediately and seek guidance from healthcare providers.