FDA Early Alert: Medline Removes or Corrects All Brand Beds After 2 Deaths and 16 Serious Injuries Reported, Over Fire and Entrapment Risks
The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) issued an Early Alert on October 29: Medline has sent customers an Urgent Medical Device Field Safety Notice announcing the discontinuation and market exit of all Medline Brand beds, and the affected beds and their associated pendants, accessories, replacement parts and bed-containing order packages are to be removed from where they are used or sold, or in some cases corrected prior to continued use.
All Medline Brand beds and associated components are affected, including homecare beds, bariatric beds and long-term care beds, as well as pendants, accessories, replacement parts and bed-containing order packages.
The FDA described two categories of risk. The first is a fire hazard: Medline Brand beds, hand-control pendants, control and motor boxes and actuators and motors may overheat under certain conditions, including excessive system loading, jammed components or motors, damage to or fluid ingress into the pendant, the use of extension cords, or the use of non-Medline or unapproved pendants or accessories. Overheating may progress to smoking, sparking, melting, burning and fire, which may lead to electrical shock and burns, and a fire could cause serious injury or death, including burns, chronic respiratory conditions from smoke inhalation, post-traumatic stress disorder related to fire incidents, or fatality. The second is entrapment and asphyxiation: there is a potential risk if Medline Brand beds are used with any bed accessories, if a user lays on a pendant being used with the bed, or if the bed is used with loose or wobbly rails, which may result in patient injury or death. As of October 20, 2026, Medline had reported two deaths and 16 serious injuries associated with these issues, and the FDA said Medline had received reports of adverse events associated with both issues.
Medline first notified affected customers on October 14 of the product removal, discontinuation and market exit. In an updated notice on October 24, Medline said affected beds, rails, mattresses and accessories may remain in use until the bed is repaired or replaced, provided users follow the updated instructions: unplug the bed from the electrical outlet, plug it in only while repositioning the patient and unplug it when not repositioning, do not use extension cords to power the bed, and whenever possible have a second person available to assist with the use and movement of the bed.
Medline is establishing two paths: repair for certain existing beds that may be eligible, and, if Medline determines that beds and accessories are not eligible for repair, replacement or a full or partial refund of the original purchase price, which may be available for certain beds, rails, mattresses and accessories purchased in the last five years. Products purchased more than five years ago remain subject to the field action and the updated instructions. The FDA also said users should not attempt to repair, modify or alter Medline Brand beds unless specifically instructed through a Medline-authorized repair process.
Customers in the United States with adverse reactions, quality problems or questions about this recall should contact Medline Recall Customer Service at 1-800-950-0128, option 7, and adverse events may be reported to Medline and to the FDA's MedWatch program. The FDA said CDRH issued the Early Alert to notify the public of a potentially high-risk device issue, that it is reviewing information about the issue, and that it will update the alert page as significant new information becomes available.
Source: GSM · USA (original Chinese edition)
Photo: 图：美国食品药品监管局（FDA）白橡树园区一号大楼。GSM联邦机构固定图库照片，经 Wikimedia Commons，公共领域。 / Photo: Building 1 of the U.S. Food and Drug Administration White Oak campus. GSM federal agency library photo, via Wikimedia Commons, public domain.
