Affected device lots may experience tip separation; field complaints reported that the tip separation can occur both prior to and during patient contact.
mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination
The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
The FDA is warning that the antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in hospitalization or even death in some cases. Most cases occurred in children 17 years and younger and in adults 60 years and o
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