August 25, 2025
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. The FDA is aware of reports of serious injuries and deaths with use of HBOT devices and is providing recommendations for health care providers and facilities to help reduce potential risks.
Recommendations for Health Care Providers and Facilities
- Review and follow the manufacturer’s instructions for use for each hyperbaric oxygen therapy (HBOT) device being used.
- Ensure fire prevention and safety measures are followed for HBOT devices.
- Be aware that there is a heightened risk of fire with use of oxygen at a high concentration.
- Ensure proper grounding equipment is used.
- Ensure proper training is provided and maintained for staff with use of HBOT devices.
- Ensure the patient is properly monitored and supervised for the duration of the treatment with use of HBOT devices.
- Ensure that manufacturer recommended cleaning procedures, maintenance intervals, and safety checks are followed for each HBOT device being used.
- Follow the manufacturer’s instructions to avoid potentially prohibited items during use of the HBOT device, including electrical or static devices. Be aware that some items may require additional grounding measures.
- Ensure patients wear clothing that is made of hyperbaric compatible materials according to the manufacturer’s instructions, such as cotton.
- Be aware that some patient clothing and some fabrics may produce more static electricity than others (such as wool and synthetic materials).
Background
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. HBOT devices are Class II medical devices and are cleared by the FDA through the 510(k) process. FDA-cleared HBOT devices can be identified by searching for Product Code CBF in the 510(k) database.
The FDA is aware of recent reports of fires that occurred with HBOT devices that resulted in serious injuries and deaths. Currently, the root cause of these events is not known. While the FDA believes that serious adverse events associated with HBOT devices are rare, health care providers and users should be aware that these events can and do occur and should follow the manufacturer’s instructions to help reduce potential risks.
FDA Actions
We are providing this information to help educate health care providers and facilities, and to help reduce the risk of harm.
The FDA will continue to work with manufacturers and professional societies to encourage training and safe use of these devices.
The FDA will continue to keep health care providers and the public informed if new or additional information becomes available.
Reporting Problems to the FDA
The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with any HBOT devices.
By promptly reporting adverse events, you can help the FDA identify and better understand the risks associated with medical devices.
Contact Information
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).
Additional Resources
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Content current as of:
08/25/2025
