FDA Warns Medline Beds Pose Fire, Entrapment and Asphyxiation Risks After Two Deaths and 16 Serious Injuries

The Food and Drug Administration warned on Thursday that Medline brand beds and accessories carry fire, entrapment and asphyxiation risks, after the company reported two deaths and 16 serious injuries linked to the products. The agency issued an Early Alert, its notice for a potentially high-risk device issue.

Medline has told customers it is discontinuing and leaving the market for all Medline brand beds and associated products. The action covers homecare beds, bariatric beds and long-term care beds, along with hand-control pendants, accessories, replacement parts and packages that contain a bed.

Fire, entrapment and asphyxiation hazards

Medline identified a potential fire hazard involving the beds, their hand-control pendants, control and motor boxes, and actuators. The FDA said electrical components can overheat under certain conditions, including heavy loading, jammed components or motors, damage to the pendant or liquid getting into it, extension cords, and pendants or accessories that Medline did not make or approve. Overheating can progress to smoking, sparking, melting, burning or fire, and can cause shock and burns. If a fire starts, the agency said, the possible outcomes include serious injury or death.

The company also received reports about risks tied to bed accessories. The FDA said using any bed accessories can lead to entrapment, and that entrapment or asphyxiation can occur if a bed is used with accessories, if a user lies on a pendant, or if the bed is used with loose or wobbly rails. As of October 20, Medline had reported two deaths and 16 serious injuries associated with these issues.

What bed owners are told to do

Medline first notified customers on October 14 that it was removing the products and exiting the market. In an updated notice on October 24, the company said affected beds, rails, mattresses and accessories may stay in use until the bed is repaired or replaced, if users follow revised instructions. Users should keep beds unplugged from outlets, plug them in only while repositioning a patient, and unplug them again when the adjustment is done. The company said extension cords must not be used to power a bed, and that a second person should help with the use and movement of the bed whenever possible.

Medline is setting up two paths for owners. Some beds may be eligible for repair. Where a bed or accessory cannot be repaired, the company will work with customers on a replacement or a full or partial refund. Repair, replacement or refund may be available for products bought in the last five years, while older products remain subject to the removal and the updated instructions. The FDA said owners should not try to repair or alter a bed unless Medline instructs them to through an authorized process. Customers can reach Medline Recall Customer Service at 1-800-950-0128, option 7, and adverse events can be reported to the company and to FDA MedWatch.

An earlier recall over the same pendants

The bed line has been in trouble before. FDA recall records show that on November 26, 2025, Medline issued an urgent recall of its homecare beds over a hazard involving the hand control pendant and its wires, which could overheat in rare cases and pose a risk of fire. The company said at the time that it had received 58 complaints reporting pendant sparking, burning, melting, smoking or fire. Medline did not immediately respond to a Reuters request for comment on Thursday.