1,320 recalls tagged with “fda regulated”.
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
Potential for attenuation degradation over time, decreasing the lifespan.
Potential for attenuation degradation over time, decreasing the lifespan.
Potential for attenuation degradation over time, decreasing the lifespan.
Potential for attenuation degradation over time, decreasing the lifespan.
Potential for attenuation degradation over time, decreasing the lifespan.
Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Augmentation devices failed bacterial endotoxin testing.
Augmentation devices failed bacterial endotoxin testing.
Augmentation devices failed bacterial endotoxin testing.
Hitachi Ltd. recalled one unit of its Proton Beam Therapy System on February 6, 2026 due to a software anomaly. The issue may result in positional discrepancies during patient treatment. The recall affects distribution in Texas and Washington D.C.
Lack of Assurance of Sterility