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# Alert on Hyperbaric Oxygen Devices
- URL: https://www.fdaweb.com/alert-on-hyperbaric-oxygen-devices/
- Published: 2025-08-25T12:00:00.000Z
- Updated: 2026-09-14T15:19:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159748

FDA is cautioning health care providers and facilities about the safe use of hyperbaric oxygen therapy (HBOT) devices following reports of serious injuries and deaths tied to their use. In a recent [safety communication](https://www.fda.gov/medical-devices/letters-health-care-providers/follow-instructions-safe-use-hyperbaric-oxygen-therapy-devices-letter-health-care-providers?utm%5Fmedium=email&utm%5Fsource=govdelivery), the agency urges providers to strictly follow manufacturers’ instructions and to reinforce fire prevention measures when operating HBOT chambers, which deliver 100% oxygen at elevated air pressure. Oxygen-rich environments can increase the risk of fire, it says, adding that it also recommends ensuring proper grounding of equipment and maintaining thorough staff training to reduce potential hazards.

FDA says it has received recent reports of fires in HBOT chambers that led to severe injuries and fatalities. The root cause of these incidents has not yet been determined, but regulators emphasize that while such events are rare, they can have devastating consequences.

HBOT is commonly used for conditions such as decompression sickness, carbon monoxide poisoning, and certain wounds. The devices are classified as Class 2 medical devices and are typically cleared through FDA’s 510(k) pathway.