CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Medline has issued an Urgent Medical Device Field Safety Notice notifying customers of the discontinuation and market exit of all Medline Brand beds and their associated pendants, accessories, replacement parts, and bed-containing order packages. Medline recommends these products 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 by this action, including:
- Homecare Beds
- Bariatric Beds
- Long-term Care Beds
- Pendants
- Accessories
- Replacement Parts
- Bed-Containing Order Packages
Full List of Affected Products
What to Do
On October 14, 2026, Medline sent all affected customers an Urgent Medical Device Field Safety Notice regarding product removal, discontinuation, and market exit. On October 24, 2026, Medline issued an updated customer notification with the following modified recommendations:
- Continued use of current Medline Brand beds, rails, mattresses, and accessories: Medline Brand beds, rails, mattresses, and accessories covered by the previously announced (October 14, 2026) product removal, discontinuation, and market exit may remain in use in accordance with the updated instructions below until the bed is either repaired or replaced. This new repair or replace procedure, detailed below, allows Medline to repair certain Medline Brand beds for its customers; other customers will either receive a replacement or full or partial refund of the original purchase price. Beds that are repaired may then be used in accordance with their Instructions for Use.
- Updated instructions: Medline Brand bed users should unplug the beds from electrical outlets. When necessary adjustments to the bed need to be made, plug the bed into an electrical outlet while repositioning the patient and unplug the bed when not repositioning the patient. Do not use extension cords to power the bed. Whenever possible, have a second person available to assist with the use and movement of the bed.
- Repair, replacement, or full or partial refund of original purchase price: Medline is establishing two paths to address affected Medline Brand beds: 1) Repair: Certain existing Medline Brand beds may be eligible for repair; 2) Replacement or full or partial refund of the original purchase price: If Medline determines that beds and accessories are not eligible for repair, Medline will work with customers to determine their eligibility for applicable replacement or full or partial refund of the original purchase price.
- NOTE: Repair, replacement, or full or partial refund of the original purchase price may be available for certain beds, rails, mattresses, and accessories purchased in the last five years. Beds, rails, mattresses, and accessories purchased more than five years ago are still subject to the field action and updated instructions above.
- NOTE: Do not attempt to repair, modify, or alter Medline Brand beds unless specifically instructed by Medline through a Medline-authorized repair process.
- For additional information regarding impacted Medline Brand beds, rails, mattresses, and accessories, or to initiate the applicable process to repair, replacement or full or partial refund of original purchase price, customers should contact Medline Recall Customer Service at 1-800-950-0128, option 7. Customers and users of impacted Medline Brand beds and related products can obtain updated information on the Medline Brand Beds and Accessories recall page.
- Reporting adverse events: Report any adverse events to Medline at [email protected] or 1-800-950-0128, option 5, and to FDA MedWatch.
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
Medline has identified a potential fire hazard involving Medline Brand beds, hand-control pendants, control/motor boxes, and actuators/motors. Under certain conditions, including but not limited to 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, the bed’s electrical components may overheat.
Overheating of the bed’s electrical components may progress to smoking, sparking, melting, burning, and/or fire. These events may increase the risk of adverse health consequences, including electrical shock and burns. If a fire occurs, there is the potential for serious injury or death, including burns, chronic respiratory conditions resulting from smoke inhalation, post-traumatic stress disorder (PTSD) related to fire incidents, or fatality. Medline has received reports of adverse events associated with this issue.
Medline has received information through post-market surveillance regarding risk when using any bed accessories. Specifically, the use of bed accessories may lead to entrapment.
There is a potential risk of entrapment or asphyxiation if: 1) Medline Brand beds are used with any bed accessories, 2) if a user lays on a pendant being used with the bed, or 3) if the bed is used with loose or wobbly rails. Entrapment or asphyxiation may result in patient injury or death. Medline has received reports of adverse events associated with this issue.
As of October 20, 2026, Medline has reported two deaths and 16 serious injuries associated with these issues.
Device Use
An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. Hospital beds include side rails that can be latched on or off and moved around.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Medline Recall Customer Service at 800-950-0128, option 7.
Additional FDA Resources
Additional Company Resources
Company-provided information is posted here by the FDA as a public service.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.