1,319 recalls tagged with “fda regulated”.
Siemens Medical Solutions USA, Inc. recalled 88 units of NAEOTOM Alpha software applications on December 19, 2025. The applications lack FDA 510(k) clearance, posing potential risks to patient safety. Healthcare providers must stop using the software immediately and follow the manufacturer's instructions.
Bisaf Strep A Self-Test from Altruan GmbH remains active in recall status after the FDA flagged lack of clearance. The Class II medical device was distributed nationwide in the United States. The hazard is lack of FDA clearance. Consumers should stop use immediately and follow manufacturer guidance.
Canon Medical Systems recalled 22 MRI systems on December 19, 2025, due to a potential ice formation hazard in the venting system. The defect could lead to a pressure build-up and helium gas release. Healthcare providers must stop using the affected devices immediately.
Tyber Medical recalled 100 units of its VOLT Wrist Treatment System on December 19, 2025. The recall stems from a manufacturing defect that affects the thread orientation of anatomical left plates. Healthcare providers and patients should stop using the device immediately.
Wondfo recalled 188 units of Streptococcal A At-Home Self-Test sold nationwide in the United States after regulators found the device was not FDA-cleared. The recall centers on lack of FDA clearance for safety and effectiveness. Consumers should stop using the test immediately and contact Altruan GmbH or their healthcare provider for instructions.
Siemens Medical Solutions USA recalled two units of its CT software applications on December 19, 2025. The software lacks FDA 510(k) clearance, posing potential risks to patients. Healthcare providers should stop using the affected software immediately.
Siemens Medical Solutions recalled software applications for certain CT systems on December 19, 2025. The applications did not receive FDA 510(k) clearance. Five units distributed worldwide are affected by this recall.
Imprimis NJOF, LLC recalled 314 boxes of Tri-Moxi+¿ intraocular injections on December 18, 2025. The recall is due to the presence of glass-like particles in the product. Consumers and healthcare providers should stop using the product immediately and contact the company for further guidance.
Vascutek recalled 37,430 Gelsoft Plus and Gelweave vascular prostheses distributed nationwide in the United States after discovering the devices were labeled with an extra month of shelf life. The expiry date was calculated from packaging rather than gel impregnation. Healthcare providers and patients should stop using the devices immediately and follow recall instructions.
Waterfront BISTRO brand Frozen Raw Shrimp was recalled on December 18, 2025, due to possible contamination with Cesium-137. Approximately 1,800 cases of the product are affected. Consumers should not consume the shrimp and seek a refund or replacement.
ZIYAD Brothers Importing recalled 2,865 cases of French Style Puff Pastry on December 17, 2025. The product may contain partially hydrogenated oils, posing a health risk. Consumers should not consume the product and seek refunds immediately.
SunMed Holdings recalled 20,583 units of Broselow Pediatric Emergency Rainbow Tape on December 15, 2025. The product contains harmful dosing errors for critical medications including Vecuronium, Flumazenil, and Ketamine. Healthcare providers and patients must stop using the tape immediately and follow recall instructions.
Diagnostica Stago issued a recall for 438 Asserachrom HPIA kits on December 15, 2025. The kits, used to detect PF4 antibodies, may produce false negative results. The affected lot is 271288, distributed worldwide including multiple U.S. states.
Philips Medical Systems recalled 12 Allura Xper FD10F systems on December 15, 2025, after identifying a potential electrical hazard. The drip tray beneath the cooling unit may not have been installed correctly, posing a risk of coolant leakage and electrical short-circuits. Users must stop using the device immediately and follow recall instructions.
So Delicious Dairy Free recalled 4,665,608 units of its Salted Caramel Cluster Cashewmilk frozen dessert on December 15, 2025. The recall follows the discovery of foreign material in the product. Consumers should not consume this item and seek a refund or replacement immediately.
Prima Vera Nueva recalled 26,457 packages of Black Bean Bonanza Tamales on December 12, 2025. The recall stems from potential contamination with Listeria monocytogenes, a dangerous bacteria. Consumers should not consume the product and seek a refund or replacement.
Prima Vera Nueva recalled 27,964 packages of BBQ Chipotle Bean & White Cheddar Tamales on December 12, 2025. The recall affects products due to potential contamination with Listeria monocytogenes. Consumers should not eat the tamales and seek a refund or replacement.
Prima Vera Nueva recalled 21,705 packages of Roasted Green Chile Tamales on December 12, 2025, due to potential Listeria contamination. Consumers should not consume the product and should seek a refund or replacement. The tamales contain organic ingredients and were distributed in California and Nevada.
Prima Vera Nueva recalled 16,790 packages of Black Bean Bonanza Tamales on December 12, 2025. The company cited potential contamination with Listeria monocytogenes, a serious foodborne pathogen. Consumers should not eat these tamales and should seek a refund or replacement.
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.