|
Early Alert: Medline Removes or Corrects All Medline Brand Beds and Accessories
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:
- Bed-Containing Order Packages
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.
Questions?
Customers in the U.S. with questions about this recall should contact Medline Recall Customer Service at 800-950-0128, option 7.
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.
|
