Medline Homecare Beds Recall Issued Over Injuries, Death Resulting From Fire Risks: FDA

Notice also warns that using non-Medline accessories or side rails with the beds may elevate the risk of patient entrapment, which has been associated with at least two additional injuries and one death.

Federal safety officials are warning healthcare providers that certain Medline Basic Homecare bed hand controllers may malfunction, leading to overheating, melting, sparking, burns, electrical shocks or even fires.

The U.S. Food and Drug Administration (FDA) announced updated use instructions for Medline Homecare Beds on February 13, following reports of at least 12 injuries and one death linked to the defective controllers.

Medline Homecare Beds are medical device beds that consist of a bedframe with a built in electric motor and remote controls that allow patients or caregivers to adjust the height and surface position.

However, regulators warn that when operating the bed above its specified weight limit, encountering an obstruction during movement, or experiencing jammed components or a malfunctioning motor, the hand controller and its cord may overheat, creating a fire hazard and posing serious risks of injury or death.

As a result of these incidents, the updated instructions advise users not to operate the bed beyond its specified weight limit and to ensure that no components are jammed or obstructed during movement. When the bed is not in use, the hand controller should be hung on the headboard or footboard and never left on the mattress.

If the motor appears jammed or malfunctions, the controls stop responding, the controller becomes hot to the touch, wiring is damaged, or smoke, sparks, or other signs of an electrical hazard occur, users should immediately unplug the bed and contact a service provider.

The affected products include the following models and their corresponding Unique Device Identifier, or UDI, numbers:

• Medline Basic Bed, Semi Electric – 40080196320999
• Medline Basic Bed, Semi Electric, Four Pack – 40080196320999
• Medline Basic Bed, Full Electric – 40080196321002
• Medline Basic Bed, Full Electric, Four Pack – 40080196321002
• Medline Basic Bed, Low Full Electric – 10080196546992
• Medlite Homecare Bed, Semi Electric – 40080196294320
• Medlite Homecare Bed, Basic, Full Electric – 40080196294344
• Medlite Homecare Bed, Low Full Electric, Basic – 40080196325901

Officials are urging health care professionals to leave the recalled beds unplugged from wall outlets, connecting them to power only when electrical adjustments are necessary.

Medline sent all affected customers a letter on November 26, recommending strict adherence to guidelines and safety instructions provided with the product, as well as the updated instructions.

For more information, Medline Industries can be contacted at 866-359-1704 or via email at recalls@medline.com.

Additionally, adverse reactions or quality problems may be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Bed Rail Entrapment Risks 

The FDA notice also warns that Medline has identified patient entrapment hazards when non-Medline accessories or side rails are used with Medline beds, an issue linked to at least two reported injuries and one death.

According to the agency, incompatible accessories or user error may cause unintended bed movement, trapping a patient between the bed frame and an attached component. Such entrapment can lead to asphyxiation, severe injury or death.

Entrapment hazards have become an increasingly common safety concern involving certain bed rails and assistive devices. Last year, Medical King recalled its bed assist rails due to design defects that contributed to at least one man’s death.

Following hundreds of entrapment deaths involving bed rails reported in recent years, new federal safety standards were issued in July 2023, to establish mandatory performance criteria and testing procedures aimed at reducing such incidents.

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