FDA issues most serious type of recall for oxygen concentrators spontaneously bursting into flames
A line of oxygen concentrators from a China-based medical equipment company have apparently been spontaneously busting into ...
Becker's Hospital Review10h
4 recent medical device recalls and corrections
JIANGSU JUMAO X-CARE Medical Equipment Co. issued a recall for the JMC5A Ni/Tru-Aire-5 Oxygen Concentrator after incidents of spontaneous fires. These fires could cause burns or worse. Patients are ...
JD Supra4d
How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
Medical Design and Outsourcing16d
Cortland Biomedical secures FDA registration
Medtech supplier Cortland Biomedical said the new designation positions it as a full-service contract manufacturer.
Hosted on MSN27d
FDA finds little handwashing, dirty equipment at McDonald's supplier linked to E. coli outbreak
FDA inspectors said they discovered "numerous equipment with apparent biofilm and large amounts of food debris" around the Taylor Farms facility in Colorado Springs, even after workers had ...
Healio26d
FDA releases draft guidance on pulse oximeter study recommendations
Panelists at an FDA Medical Devices Advisory Committee meeting in 2022 previously pointed out that pulse oximeters show clear “disparate performance” for darker skin pigmentation. The FDA ...