FDA warns of fire hazard in Medline beds

The Food and Drug Administration published an early alert Thursday about Medline brand beds, reporting two deaths and 16 serious injuries linked to the beds. The alert also notes that Medline plans to discontinue the beds and related products and exit the hospital bed market. Medline said it would remove the beds, rails, mattresses and accessories from circulation and offer repair or replacement options. Customers can keep using the devices under new instructions until they are repaired or replaced.

Recall details and customer guidance

Medline first notified customers on Oct. 14 that it was voluntarily recalling its beds and related parts. An updated notice on Oct. 24 said the recalled items could stay in use while users follow revised instructions. Medline would repair some beds and offer replacements or refunds for others. Devices bought in the last five years are covered. Users should unplug the beds when not repositioning a patient, avoid extension cords, and have a second person help whenever possible. The updated guidance was issued in consultation with the FDA.

The fire hazard is linked to the beds' hand-control pendants, control boxes, motor boxes and actuators. The electrical components can overheat when the system is overloaded, when a component jams, or when an extension cord is used. Overheating can cause smoking, sparking, melting, burning or fire, and can raise the risk of electrical shock. Medline has also received reports of entrapment or asphyxiation, which can cause injury or death, especially when beds are used with loose or wobbly rails or when a patient lies on a pendant.

Medline's recall covers all its brand beds, including home-care, bariatric and long-term-care models, along with their pendants, accessories and replacement parts. Users can keep using the beds under the updated instructions until a repair or replacement is done. Drive Medical said it had accelerated its bed manufacturing capacity to keep home-care providers supplied, and expects significant additional inventory from mid-November.

Customers who want a repair, replacement or refund should contact Medline Recall Customer Service at 1-800-950-0128, option 7, or email [email protected]. Adverse events can be reported to Medline at 1-800-950-0128, option 5, or through the FDA MedWatch program online. The FDA's Office of Supply Chain Resilience can be reached at [email protected] for questions about shortages or disruptions.