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FDA Safety Communication – Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices
On August 25, 2025, the U.S. Food and Drug Administration (FDA) issued an important Letter to Health Care Providers reminding clinicians and facilities of the critical importance of following manufacturer instructions for safe use of hyperbaric oxygen chamber (HBO2) devices. This action follows recent reports of fires, injuries, and fatalities associated with HBO2 device use.