370 recalls tagged with “nhtsa regulated”.
LeMaitre Vascular recalled 28 Artegraft Collagen Vascular Grafts distributed nationwide in 17 states. The grafts use bovine carotid arteries sourced from a supplier not reviewed by the appropriate regulatory authority. Patients and healthcare providers should stop using the device immediately and contact LeMaitre Vascular for instructions.
Northeast Scientific recalled 141 units of the NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter nationwide in the United States. The device may have breaches in the sterile barrier packaging that could compromise sterility. Hospitals and patients should stop using the device immediately and await instructions from Northeast Scientific Inc. or their clinicians.
Baxter Healthcare recalls 49,200 CONTINU-FLO IV Solution Sets distributed nationwide in the United States. IV sets may leak. Healthcare facilities and patients should stop using the device immediately and follow Baxter's recall instructions.
Northeast Scientific Corp. recalled 1,019 units of the NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. The model is not cleared for marketing in the United States. The recall cites potential breaches in sterile barrier packaging that could compromise sterility. Patients and healthcare providers should stop using the device immediately. Follow the manufacturer's recall instructions
Baxter Healthcare recalled 8,368 CLEARLINK SYSTEM CONTINU-FLO IV sets nationwide after reports the devices may leak. The non-vented sets include a 0.2-micron filter, three CLEARLINK luer activated valves and a backcheck valve, and measure 102 inches in length. Hospitals and clinicians should stop using these units immediately and follow Baxter's recall instructions.
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 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 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
Camp USA recalled Nimbus Lock Carabiners sold through various retailers after a safety concern over the automatic closing mechanism. The carabiner's automatic closing mechanism can break and prevent the gate from closing, creating a fall risk. Stop using the recalled carabiners immediately and contact CAMP for inspection, repair or replacement.
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.
Siemens Medical recalled 27 MAGNETOM Vida Fit MRI systems after a potential helium containment rupture was identified. Ice blockage in the magnet venting system may prevent helium from escaping, leading to a dangerous pressure build-up. Patients and healthcare providers must stop using the device immediately and follow the manufacturer's instructions.
Siemens Medical Solutions USA recalled 46 MAGNETOM Verio Dot Upgrade MRI systems sold to hospitals worldwide after an ice blockage could prevent venting during a quench. The blockage could cause pressure to build in the helium containment system, potentially rupturing it and releasing helium into the scanning room. Hospitals and providers should stop using the device immediately and follow Siemens
Sunrise Creamery Monterey Jack Cheese with Dill Pickles is recalled by Middlefield Original Cheese Cooperative after FDA findings indicate potential Listeria monocytogenes contamination. The recall covers two SKUs in 6 oz and 1.25 lb sizes, distributed to Ohio, Pennsylvania, Wisconsin and Texas. Consumers should discard affected cheese and contact the cooperative for refund or replacement.
Zydus Lifesciences recall remains active for 270,125 vials distributed across MS, OH, LA and Puerto Rico. The FDA notice cites failed impurities and degradation specifications as the reason. Immediate discontinuation is advised for healthcare providers and patients with ongoing prescriptions. Contact Zydus Pharmaceuticals USA Inc for guidance.
Kia America, Inc. recalls 2025 K4 and Sorento vehicles at Kia dealerships after finding the connecting rod bolts may have been improperly tightened. The defect can cause a loss of drive power, increasing the risk of a crash. Owner notification letters are scheduled to be mailed September 12, 2025, and dealers will replace the sub engine assembly at no charge.
AvKare recalled 1,512 cartons of CHLORPROMAZINE HYDROCHLORIDE 50 mg tablets distributed nationwide in the U.S. for the presence of a foreign substance. The recall is active as of Sept. 17, 2025. Consumers and healthcare providers should stop using this product immediately and contact AvKARE or a healthcare provider for guidance.
Ford recalls 2025 Explorer and Aviator vehicles sold through Ford dealers due to a faulty body control module that can prevent trailer tail lights from illuminating. The defect may reduce visibility for other drivers when towing a trailer. Interim letters alert owners starting Oct 13, 2025, with a final remedy anticipated in April 2026. Ford will perform the repairs at no charge and provide the an
Ford is recalling certain 2025-2026 F-550 SD, F-450 SD, F-350 SD, F-250 SD, and 2025 F-150 vehicles because the instrument panel may fail at startup. The recall covers 2025-2026 models. Ford will provide an IPC software update via dealer service or OTA at no cost. Owner letters were mailed September 5, 2025. Contact Ford customer service at 1-866-436-7332. Recall number 25S88.
IBC Technologies recalled CX Series Combi Boilers for burn hazards. The recall covers CX-199 and CX-150 models with specific serial ranges. Consumers should stop using recalled boilers immediately and contact IBC for a free in-home repair to install a mixing valve.
Frontier Devices and Folsom Metal Products issued a high-risk recall for 490 units of the 16 mm Distraction Pin, REF 301.916S1, distributed nationwide in the United States. The labeling includes shelf life that has not been validated. Patients and healthcare providers should stop using the device immediately and follow recall instructions.