FDA Safety Communication Urges Caution for Hyperbaric Oxygen Therapy (HBOT) Devices

Published: 08/28/2025

Sources:
  • Food and Drug Administration
Relevant To:
  • Critical Access Hospitals,
  • Hospitals

The U.S. Food and Drug Administration (FDA) is reminding health care providers and facilities about the safe use of hyperbaric oxygen therapy (HBOT) devices and the importance of following the manufacturer’s instructions for use. Hyperbaric oxygen therapy is a type of treatment that involves breathing 100% oxygen in a special chamber. The air pressure inside is raised to a level that is higher than normal air pressure. The increased air pressure in the chamber helps the lungs collect more oxygen

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