FDA Issues Early Alert on All Medline Beds After 2 Deaths and 16 Serious Injuries

The FDA has issued an Early Alert on every bed Medline sells under its own brand, citing a fire hazard and a risk of entrapment and asphyxiation. As of Oct. 20, Medline had reported two deaths and 16 serious injuries tied to the problems.

The agency labels the alert a notice of a "potentially high-risk device issue." It says it is still reviewing the information and will update its web page as significant new information arrives.

What Medline told customers

On Oct. 14, 2026, Medline sent customers an Urgent Medical Device Field Safety Notice. It announced the discontinuation of all Medline-brand beds and their pendants, accessories, replacement parts and order packages that include a bed. The company is leaving the market entirely.

On Oct. 24, Medline issued updated recommendations. The changes let customers keep using the beds under revised instructions until the beds are repaired or replaced.

The company says the electrical components can overheat under certain conditions. Those conditions include excessive loading, jammed components or motors, damage to the pendant or fluid getting into it, extension cords, and non-Medline or unapproved pendants and accessories.

Overheating can lead to smoking, sparking, melting, burning or fire, according to the FDA alert. The agency lists burns, electrical shock, chronic respiratory problems from smoke inhalation, post-traumatic stress disorder and death as possible outcomes.

The entrapment problem

A separate hazard involves accessories. Medline's post-market surveillance found a risk of entrapment or asphyxiation when a bed is used with any accessory, when a user lies on the pendant, or when the rails are loose or wobbly.

Medline has received reports of adverse events tied to both the fire and entrapment issues, the FDA says.

What customers are being told to do

Medline will repair some beds. Where a bed or accessory cannot be repaired, customers may get a replacement or a full or partial refund. Those options apply to products bought in the past five years. Older products remain covered by the safety instructions and the market exit.

Users should plug a bed into an outlet only while repositioning the patient, and unplug it afterward. Whenever possible, a second person should be available to help. Customers can call Medline at 800-950-0128, option 7.

Medline says customers can keep using the products in line with its instructions. In a statement, it said: "We believe this action best supports our commitment to product quality and safety for healthcare providers and the patients and communities they serve." It added that it recognizes "the impact this decision may have on the healthcare system."

The money

In an Oct. 21 SEC filing on Form 8-K, Medline said net sales of the affected products came to about $60 million for the year ended June 27. The company estimated $220 million in costs tied to the field action. That is more than three and a half times the annual sales of the product line.

Medline is publicly listed, with a market value of $43 billion, according to CBS News.

Not the first warning

This action follows earlier ones. The law firm Levin & Perconti, which handles nursing home cases and has a stake in this kind of litigation, says Medline began a narrower recall in fall 2025 covering two lines of home care beds and their pendants. The firm says the FDA classified that recall as Class I, its most serious category, and that those notices did not tell users to stop using the beds.

The firm also says Medline had reported 12 injuries and one death tied to the electrical problem by Dec. 18, 2025. It adds two injuries and one death tied to unapproved accessories, and that in February the FDA recommended keeping certain Medline beds unplugged unless an adjustment needed power. The firm says it is unclear whether any of those cases occurred in nursing homes. Those figures come from the law firm, not the FDA alert.

In May 2024, Medline recalled about 1.5 million Bed Assist Bar portable bed rails in the U.S. and Canada after two women died of entrapment. The Consumer Product Safety Commission called it the seventh adult bed rail recall since 2021. The agency counted at least 284 deaths linked to adult bed rails from 2003 to 2021.

Steve Levin, the firm's founder, told The Washington Post at the time that families should "be vigilant advocates for their loved ones in a nursing home." He advises calling the facility, raising the recall and asking about the relative's mattress and rails.

What remains unanswered

Medline has not said how many beds are affected. The firm says the company's list of affected models runs eight pages, and some beds were sold more than five years ago. The FDA has not yet said how it will classify the current action, and it says it will post updates as its review continues.