FDA Early Alert Covers All Medline Beds After Two Deaths and Market Exit

The US Food and Drug Administration has issued an early alert covering all Medline Brand beds and associated components, after Medline reported two deaths and 16 serious injuries linked to fire and entrapment hazards and announced it would exit the bed market.

"CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue," the agency's Center for Devices and Radiological Health said in the notice. "All Medline Brand beds and associated components are affected by this action," the FDA said. The action covers homecare, bariatric and long-term care beds, hand-control pendants, accessories, replacement parts and order packages that contain beds.

Fire and entrapment hazards

According to the FDA, Medline has identified a potential fire hazard involving overheating of electrical components in the beds, hand-control pendants, control and motor boxes, and actuators or motors. "Overheating of the bed's electrical components may progress to smoking, sparking, melting, burning, and/or fire," the notice states. Possible contributing factors listed include excessive loading, jammed components or motors, pendant damage or fluid ingress, extension cords, and the use of non-Medline pendants or accessories.

The notice also describes entrapment and asphyxiation risks when the beds are used with accessories, when a user lies on a pendant, or when rails are loose or wobbly. "Entrapment or asphyxiation may result in patient injury or death," it says.

"As of October 20, 2026, Medline has reported two deaths and 16 serious injuries associated with these issues," the FDA said. The notice does not state how many beds are affected.

From market exit to repair option

Medline first notified customers in an urgent field safety notice dated October 14, which announced the removal, discontinuation and market exit of its beds and recommended that products be removed from where they are used or sold, according to the FDA.

On October 24, Medline updated that communication. In a statement on its newsroom, the company said that "in consultation with the U.S. Food and Drug Administration," it was revising its instructions so that beds, rails, mattresses and accessories "may remain in use in accordance with the updated instructions below until the bed is either repaired or replaced."

Under the updated instructions, users should unplug the beds, plug them in only while repositioning a patient, avoid extension cords, and have a second person assist with use and movement of the bed whenever possible, Medline said. The company said certain beds may be eligible for repair, while others may qualify for replacement or a full or partial refund of the original purchase price, generally for items bought in the last five years. Items purchased earlier remain subject to the field action and updated instructions.

Medline's statement adds: "Do not attempt to repair, modify or alter Medline Brand beds unless specifically instructed by Medline through a Medline-authorized repair process."

Earlier action on homecare beds

The FDA notice links to an earlier communication, dated February 13, 2026, in which Medline updated use instructions for its electronic homecare beds. Medline directs customers to its recall customer service line for repair, replacement or refund requests, and the FDA asks that adverse events be reported to Medline and to the agency's MedWatch program.