Fire Risk, Device Quality and Clinical Oversight

Urgent first

If there is fire, smoke or a burning smell at or near an oxygen or hyperbaric chamber, get everyone away from it and call 911 (US) or your local emergency number. This page describes risks and oversight only. It does not give operating or setup instructions.

Why fire is the central worry

Hyperbaric oxygen therapy (HBOT) is breathing 100% oxygen in a chamber with raised air pressure. [1] The FDA's August 25, 2025 letter to providers says there is a heightened risk of fire with oxygen at high concentration and that the agency is aware of reports of serious injuries and deaths with HBOT devices. [1] It also says that the root cause of recent fires is not known and that it believes serious events are rare, but "can and do occur". [1] Burns and other physical harms are covered in Burns, Pressure-Related Injury and Oxygen Toxicity.

What the FDA asks facilities to do

Recommendations in the letter include: follow the maker's instructions for each device; follow fire prevention and safety measures; use proper grounding; train staff and keep training current; monitor and supervise the patient for the whole treatment; follow cleaning, maintenance and safety-check schedules; avoid prohibited items such as electrical or static devices; and use compatible clothing. [1] The letter notes that some patient clothing and fabrics, such as wool and synthetics, can produce more static electricity. [1] These are expectations for providers. They are not do-it-yourself instructions.

Device quality: what "cleared" means here

The FDA says HBOT devices are Class II medical devices cleared through the 510(k) process, and that cleared devices can be found under product code CBF in its database. [1] Clearance is device-specific. A clearance for one chamber does not make another chamber, a different pressure design or a home-built unit cleared. See Claim Check: "FDA Registered" vs Product Approval.

A 2026 critical review in Undersea & Hyperbaric Medicine examined soft-sided and some "mild" low-pressure hard-sided chambers. It says they are marketed as safe and effective for various conditions but lack compliance with critical regulatory and safety standards and codes, which raises risks including ear and lung barotrauma, suffocation, fire hazards, structural failure and, in extreme cases, death. [2] That is a review by specialists, based on regulatory guidance, safety reports and marketing practices, and it makes the point that oversight is inconsistent. A second 2026 review says both mild and traditional hyperbaric treatment are associated with potentially life-threatening events including chamber explosion or fire, and that compliance with safety standards is not universally mandated and may vary among facilities. [3]

Home and unsupervised use

An FDA adverse event report from July 2025 records a death in which responders concluded that a flash fire occurred during self-treatment inside a sealed chamber at a health clinic. Several electronic devices and battery packs were found in the chamber, and lithium-ion batteries were suspected as an ignition source. [4] This is a single report with a suspected cause, not a rate. It illustrates why supervision, grounding and rules about what may enter the chamber exist.

"Proper evidence not found" for how many home chambers are in use, or how often they catch fire: I checked FDA communications, FDA adverse event records and PubMed reviews, and none gave counts.

What clinical oversight means

Harvard Health, reporting the FDA position, says the FDA recommends HBOT only at an accredited facility. [5] Oversight includes a physician who decides whether treatment is appropriate, trained staff, and a facility that follows fire safety rules. It does not mean the treatment works for every condition a facility advertises. Those questions are covered in Unapproved Uses of Physical and Gas-Based Interventions and Hyperbaric Oxygen: Wellness and Longevity Claims.

Questions worth asking any provider

• Which exact chamber is used, and is it FDA cleared for the stated use?
• Is the facility accredited, and who supervises each session?
• What rules apply to clothing, devices and batteries?
• Is the treatment for an approved condition? See Hyperbaric Oxygen: Established Indications.