185 recalls tagged with “federal law violation”.
Sedecal recalled 24 units of its Mobile X-ray system on June 10, 2025, due to improper cleaning risks. The equipment is not water-resistant and can lead to safety issues if not cleaned according to the manual. Healthcare providers and patients must stop using the device immediately.
Sedecal recalled one mobile X-ray system on June 10, 2025, due to concerns about improper cleaning. The model SM-40HF-B-D-C is not water-resistant and poses risks if not cleaned according to instructions. Users must stop using the device immediately and follow recall instructions.
SEDECAL SA recalled six units of its Mobile X-ray system on June 10, 2025. The device is not water-resistant and improper cleaning can lead to hazards. 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.