185 recalls tagged with “federal law violation”.
Tandem Diabetes Care recalled 122,958 insulin pumps on August 5, 2025. A software defect may cause unexpected insulin boluses, leading to hypoglycemia. Patients should stop using the devices immediately and follow the manufacturer's instructions.
Beckman Coulter recalled 116 DxC 500i Clinical Analyzer modules on August 4, 2025, due to potential processing delays. The defect may impact the accuracy of test results when ordering certain tests simultaneously. Healthcare providers and patients must stop using the device immediately and follow recall instructions.
S.I.N. Implant System Ltda recalled 4,367 dental implants on July 30, 2025, due to improper storage conditions. The recalled products may have compromised packaging, affecting their quality and performance. Patients and healthcare providers should stop using these devices immediately.
American Health Packaging recalled 26,992 blister packs of Sucralfate Tablets on July 29, 2025. The recall follows CGMP deviations that affect product quality. Consumers should stop using the product immediately and seek guidance from healthcare providers.
Aiho recalled five-drawer dressers on July 24, 2025, due to tip-over and entrapment hazards. The dressers, model number AP23-W, do not meet safety standards set by the STURDY Act. Consumers should stop using the product if it is not anchored to a wall.
Quest International recalled 376 Measles IgM Test Kits on July 17, 2025. The kits lack premarket approval or clearance from the FDA. Healthcare providers and patients must stop using these kits immediately.
AUGNORYE recalled padded crib bumpers on July 10, 2025, after reports of suffocation hazards. The bumpers violate federal safety regulations. Consumers should stop using them immediately and request a refund.
SPPTTY recalled kids bicycles on July 10, 2025, due to lead poisoning risks. The bicycles exceed federal lead content limits, posing serious health hazards to children. Consumers should stop using the bicycles and seek refunds immediately.
North American Rescue recalled 552 Junctional Emergency Treatment Tools on July 1, 2025. The device may have a manufacturing defect that compromises its structural integrity. Healthcare providers should stop using it immediately and follow recall instructions.
Quidel Corporation recalled 22,470 Dipstick Strep A Tests on June 17, 2025, due to potential false positive results. The recall affects tests distributed in multiple U.S. states and internationally. Patients and healthcare providers must stop using the device immediately.
SEDECAL SA recalled four units of its Mobile X-ray system on June 10, 2025, due to improper cleaning risks. The manufacturer warns the equipment is not water-resistant and requires strict adherence to cleaning instructions. Users must stop using the device immediately and follow recall instructions for safety.
SEDECAL SA recalled one unit of its Mobile X-ray system on June 10, 2025. The device is not water-resistant and requires strict cleaning per the manual. Improper cleaning may lead to serious safety risks for patients and healthcare providers.
SEDECAL SA recalled 6 units of its Mobile X-ray system on June 10, 2025. The equipment is not water-resistant and improper cleaning may lead to serious risks. Patients and healthcare providers must stop using the device immediately and follow recall instructions.
Sedecal recalled six units of its mobile X-ray system on June 10, 2025. Users must stop using the device due to a risk of malfunction if not cleaned properly. The equipment is not water-resistant, which may lead to safety hazards.
SEDECAL SA recalled 22 units of its Model SM-32HF-Batt Mobile X-ray system on June 10, 2025. The recall alerts users that the equipment is not water-resistant and requires strict cleaning per the manual. Improper cleaning may lead to serious safety risks.
Sedecal recalled three Mobile X-ray systems on June 10, 2025, after warning users about improper cleaning risks. The equipment is not water-resistant and can pose dangers if not maintained according to the manual. This recall affects units distributed in California, Illinois, and New Jersey.
SEDECAL SA recalled eight mobile X-ray systems on June 10, 2025. The recall follows warnings that the devices are not water-resistant and must be cleaned per the manual. Users must stop using the device immediately to avoid potential injuries.
SEDECAL SA recalled four units of its Mobile X-ray system on June 10, 2025, due to water-resistance issues. Improper cleaning can lead to serious safety hazards. Users must stop using the product immediately and follow recall instructions.
Sedecal recalled 39 units of its Mobile X-ray system on June 10, 2025. The device is not water-resistant and may pose a hazard if improperly cleaned. Users must follow specific cleaning instructions to avoid potential risks.
SEDECAL SA recalled six units of its mobile X-ray system on June 10, 2025. The equipment is not water-resistant and requires strict cleaning protocols. Improper cleaning could have serious consequences for users.