FDA Reminds Providers to Follow Safe-Use Instructions for HBOT Devices
After reports of fires, injuries and deaths, the FDA's August 2025 letter urges providers to follow HBOT device safe-use instructions - and it matters for buyers too.
What the FDA published
On 25 August 2025 the U.S. Food and Drug Administration issued a Letter to Health Care Providers titled 'Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices'. The letter is a reminder rather than a recall: it asks providers and facilities to review and follow each device manufacturer's instructions for use, and it restates basic fire-safety expectations for pressurised, oxygen-rich environments.
The agency said it had received reports of fires involving HBOT devices that resulted in serious injuries and deaths, with at least two fatal incidents reported in the United States in 2025. The FDA also stated that the root cause of these events was not yet known. In other words, the communication documents a safety signal and asks for disciplined operation - it does not claim to have pinpointed a single defective product or supplier.
The core recommendations
The recommendations centre on fire prevention. High concentrations of oxygen make combustion easier and faster, so the letter asks facilities to ensure fire-prevention measures are in place and that devices are properly grounded. Staff should receive ongoing training and keep the heightened fire risk in mind at all times.
Patient-side measures are equally concrete. Patients should be continuously monitored during treatment and should wear manufacturer-recommended, hyperbaric-compatible clothing - typically cotton - because wool and synthetic fabrics can build up static electricity. The agency also points to following the maintenance and servicing schedules defined by the manufacturer rather than improvising them.
How these devices are regulated
Hyperbaric oxygen therapy devices intended for the conditions the FDA has cleared are Class II medical devices in the United States. They reach the market through the 510(k) pathway, in which a manufacturer demonstrates substantial equivalence to a legally marketed device. FDA-cleared HBOT systems can be identified by the product code CBF in the agency's 510(k) database.
This matters when you are comparing hardware. A chamber marketed for wellness or 'mild' use is not the same regulatory object as a 510(k)-cleared HBOT device, and the two are not interchangeable on paper or in practice. If you are weighing a purchase, our buyer's guide at buying guide walks through clearance status, intended use and the paperwork worth requesting before money changes hands.
What it means for buyers and operators
For clinics and private buyers, the practical takeaway is that documentation and supervision are not optional extras. Confirm that a device is cleared for its intended use, keep the manufacturer's instructions accessible, and budget for trained operators and scheduled maintenance rather than treating the chamber as a plug-and-play appliance. The FDA also encourages users to report suspected device problems to the agency, which is how safety signals like this one are detected in the first place.
None of this is medical advice. Whether hyperbaric oxygen therapy is appropriate for a given person, and under what supervision, is a decision to make with a qualified physician who knows the individual case.