185 recalls tagged with “federal law violation”.
ITS recalls 70 Olecranon Plates with Angular Stability distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than described in the IFU. Patients and healthcare providers should stop using this device immediately and contact ITS or their healthcare provider for instructions.
I.T.S. recalled 46,637 pelvic reconstruction system components nationwide in the United States after MRI safety testing showed higher RF-induced heating than the IFU stated. The issue centers on MRI heating under certain conditions that could injure patients. Patients should stop using the devices and follow manufacturer recall instructions.
ITS GmbH recalled 510 units of the I.T.S Straight Plate with Angular Stability after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions. The recall covers multiple article numbers across forearm and straight plates and distributions nationwide in the United States. No injuries or incidents have been reported at this time. Healthcare providers andpatients
Iristar recalled Minoxidil Spray Bottles on January 22, 2026, due to a serious poisoning risk to children. The product fails to meet child-resistant packaging standards mandated by the Poison Prevention Packaging Act. Consumers should stop using the product immediately and secure it out of children's reach.
Dynarex Obstetrical Towelettes Cleanser is under an active FDA recall as of Jan. 20, 2026. The recall cites CGMP Deviations that could affect product quality. Consumers and healthcare providers should stop using the product immediately and contact ACME United Corporation or a healthcare provider for guidance.
Med-Nap Cleansing Towelettes, manufactured by Acme United Corporation, were recalled nationwide on January 20, 2026. The recall cites CGMP deviations in manufacturing for benzalkonium chloride 0.13% towelettes. Consumers and healthcare providers should stop using the product immediately and contact Acme United for guidance.
ACME United Corporation is recalling Savannah Antibacterial Towelettes nationwide after CGMP deviations in manufacturing. The deviations may affect product quality and safety. Stop using the product immediately and contact ACME United or your healthcare provider for guidance.
ACME United Corporation recalled BZK Antiseptic Towelettes sold for Food Service Resources nationwide after CGMP deviations were found. The recall is Class II and high risk. Consumers and healthcare providers should stop using this product immediately and follow recall guidance.
Bakkavor recalled 2,337 cases of Basil Pesto & Mozzarella Pizza distributed by Grocery Delivery E-Services to 10 states. Metal fragments were found in the bread component linked to roasted tomatoes from an ingredient supplier. Consumers should stop using the product and contact Bakkavor for refunds or replacements.
Edermy LLC recalled 11,202 medical devices on January 14, 2026. The recall affects models P2HC-A, P2HC-S, and P2HC due to lack of proper FDA clearance. Patients and healthcare providers should immediately cease use of these devices and follow recall instructions.
Sevillo Fine Foods recalled 2,372 units of Slow Roasted Diced Tomatoes distributed to California and North Carolina. The product may contain metal fragments. Consumers should not consume the product and should contact Sevillo Fine Foods for refunds or replacements.
Rattan recalled its 6-Drawer Dressers on January 8, 2026, due to serious tip-over and entrapment risks. The unstable dressers pose a significant danger to children, especially if not anchored. Consumers should stop using these dressers immediately and seek a full refund.
Ford Motor Company recalled certain 2025 F-250 SD vehicles due to a defect in the brake system. The brake booster pushrod retaining spring may not have been installed, risking sudden brake failure. Owners should not drive these vehicles until repairs are completed.
Gold Star Distribution recalled various feminine hygiene products on December 26, 2025. The recall affects brands including KOTEX and ALWAYS due to potential rodent contamination in their distribution center. Consumers should stop using these products immediately and follow manufacturer instructions for return.
Philips North America recalled 146 units of Patient Information Center software on December 22, 2025. A software patch modifies Mobile Event Notification filter settings without notifying users. The recall affects units distributed worldwide, including 41 in the U.S.
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.
Hologic, Inc. recalled 681,870 units of the Brevera Breast Biopsy System on December 15, 2025, due to presence of particulates that can enter breast tissue. The recall affects devices distributed nationwide in the U.S. Healthcare providers and patients must stop using the device immediately.
Prima Vera Nueva recalled approximately 103,556 tamale packages on December 12, 2025, due to potential Listeria contamination. The recall affects Mushroom, Spinach & Salsa Tamales with 2 Cheeses sold in California and Nevada. Consumers should not eat these products and seek refunds immediately.
Intuitive Surgical recalled 86,904 da Vinci S and Si Monopolar Curved Scissors instruments sold worldwide to hospitals and surgical centers. The recall cites increased complaints of broken or frayed grip cables on reusable instruments. Healthcare facilities should stop using the device immediately and follow the manufacturer’s recall instructions.
Honda recalled certain 2021-2025 Acura TLX, 2023-2025 Acura MDX, and 2023-2025 Honda Pilot vehicles due to a brake pedal defect. The brake pedal pivot pin may not be secured properly, increasing the risk of a crash. Owner notification letters were mailed on July 29, 2025.