185 recalls tagged with “federal law violation”.
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 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 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.
Omnia Medical recalled 15 units of the TiBrid Stand Alone Intervertebral Body Fusion Device on July 15, 2024. The recall follows reports of failure of fusion system instruments in the field. Healthcare providers and patients must stop using the device immediately.
Foundation Medicine recalled 18 units of the FoundationOne Liquid CDx (F1LCDx) on November 8, 2022. Reports sent to customers lacked the necessary companion diagnostic Claims Page. The issue affects customers across multiple U.S. states and in Japan and Singapore.