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The FDA issued an Early Alert about Medline’s action covering all Medline Brand beds and associated components, citing potential fire and entrapment hazards. Medline’s updated October 24 notice says affected products may remain in use under specific instructions until repaired or replaced; as of October 20, the company had reported two deaths and 16 serious injuries associated with the issues.
The U.S. Food and Drug Administration has issued an Early Alert about Medline’s action to discontinue and remove or correct all Medline Brand beds and associated products, citing potential fire, entrapment and asphyxiation hazards. The FDA says Medline reported two deaths and 16 serious injuries associated with the issues as of October 20, 2026; Medline’s updated customer instructions allow affected products to remain in use under specified conditions until repair or replacement.
The affected products include homecare, bariatric and long-term-care beds, along with bed rails, mattresses, hand-control pendants, accessories, replacement parts and packages containing beds. The FDA says Medline sent an urgent field safety notice to affected customers on October 14, 2026, notifying them of the discontinuation and market exit. Medline issued an updated customer notice on October 24 with revised recommendations and routes for repair, replacement or a possible refund.
Under the updated instructions, users should unplug affected beds when they are not being adjusted. If an adjustment is needed, the bed may be plugged in while repositioning the patient, then unplugged afterward. Medline says not to use extension cords and recommends having a second person available to help with bed use and movement whenever possible. Users should not attempt to repair, modify or alter a bed unless Medline specifically directs them through an authorized repair process.
Medline is establishing a repair process for certain beds. If a bed or related product is not eligible for repair, the company will work with customers to determine eligibility for a replacement or a full or partial refund of the original purchase price. The FDA notice says these remedies may be available for certain beds, rails, mattresses and accessories bought within the last five years. Older products remain subject to the field action and updated use instructions. Customers can contact Medline Recall Customer Service at 1-800-950-0128, option 7, for information or to begin the process.
Fire and Entrapment Risks for Users
The alert concerns equipment used to support people who may have limited mobility, including patients in homecare and long-term-care settings. A fire or entrapment incident involving a bed can put a user at risk of burns, electrical shock, asphyxiation or other serious harm. The FDA says fires could also result in smoke-related respiratory conditions and other consequences; it warns that serious injury or death is possible.
Medline identified conditions that could contribute to electrical components overheating, including excessive system loading, jammed parts or motors, damage to or fluid entering a pendant, use of extension cords, and use of non-Medline or unapproved pendants or accessories. Overheating may lead to smoking, sparking, melting, burning or fire, according to the FDA’s summary of the company’s findings. Separately, the agency says accessories, a user lying on a pendant, or loose or unstable rails could create entrapment or asphyxiation risks.
The reported toll underscores why customers should check whether their equipment is affected and follow the revised instructions rather than relying on assumptions about a bed’s age or condition. The FDA says products bought more than five years ago are still covered by the field action, even though repair, replacement or refund options may be limited to certain products purchased within the past five years.
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October Notices and Updated Instructions
The FDA’s Center for Devices and Radiological Health issued the Early Alert to notify the public of what it describes as a potentially high-risk device issue. The agency says it is reviewing information and will update its alert page when significant new information becomes available. The notice describes Medline’s action as a discontinuation and market exit for its branded beds and related products, paired with removal or correction recommendations.
Medline’s October 24 customer notice modified the earlier recommendation by setting out a repair-or-replace process and permitting continued use under the revised instructions until a bed is repaired or replaced. The FDA says a bed that has been repaired may be used in accordance with its Instructions for Use. The customer notice also states that decisions about repair eligibility and any replacement or refund will be handled through Medline’s process.
Medline’s reported adverse-event count is tied to the specific hazards described in the alert and is current as of October 20, 2026. The FDA notice also says Medline received adverse-event reports related to both the overheating issue and the potential entrapment hazards. The alert does not provide details about the reported cases, such as when they occurred or which specific models were involved.
“Affected beds may remain in use under the updated instructions until the bed is repaired or replaced.”
— Medline, as summarized in the FDA alert
Cases, Models and Remedy Eligibility
The FDA’s supplied alert does not identify the specific models, serial numbers or production dates associated with the reported deaths and injuries. It refers readers to a full list of affected products and Medline’s recall page, but the information provided here does not include that product-by-product list. Customers should confirm directly with Medline whether a particular bed or accessory is covered.
It is also unclear from the notice how many products are eligible for repair, how long repairs or replacements may take, and how Medline will calculate any full or partial refund. The FDA says remedies may apply to certain products purchased within the last five years, but older products remain subject to the field action. The agency has not stated whether its review has reached a conclusion about the cause or scope of the reported events.
The number of reported deaths and injuries is attributed to Medline and is dated October 20, 2026. The FDA alert does not provide further information about the circumstances of those reports, so no additional conclusions about individual cases can be drawn from the notice.
Customer Checks and FDA Updates
Owners and care providers should use Medline Recall Customer Service at 1-800-950-0128, option 7, to ask whether a product is affected and to discuss repair, replacement or refund eligibility. The FDA says users should follow the updated unplugging instructions, avoid extension cords, and not attempt unauthorized repairs or modifications. The alert also directs customers to Medline’s recall page for updated product information.
Anyone experiencing an adverse event should report it to Medline at QualityAssurance@medline.com or 1-800-950-0128, option 5, and to the FDA’s MedWatch reporting program, according to the notice. The FDA says it is continuing to review information and will update its Early Alert page as significant developments become available. The timing and scope of any further corrective steps have not been specified.
Key Questions
Which Medline products are included in the alert?
The action covers all Medline Brand beds and associated components, including homecare, bariatric and long-term-care beds, pendants, rails, mattresses, accessories, replacement parts and bed-containing packages. Customers should check Medline’s product list or contact the company to confirm whether a specific item is affected.
Can affected beds still be used?
Medline’s updated October 24 instructions say affected beds may remain in use until repaired or replaced if users follow the directions. They should unplug the bed when it is not being adjusted, plug it in only while repositioning the patient when necessary, and unplug it afterward. The notice says not to use extension cords.
What should customers do if a bed is affected?
Contact Medline Recall Customer Service at 1-800-950-0128, option 7 to ask about the product and the applicable repair, replacement or refund process. Do not attempt to repair or modify a bed unless Medline directs the work through an authorized process.
Are older beds covered by the action?
Yes. The FDA notice says beds, rails, mattresses and accessories purchased more than five years ago remain subject to the field action and updated instructions. Repair, replacement or refund options may be available for certain products bought within the last five years.
What hazards prompted the alert?
The alert describes potential electrical overheating, fire, entrapment and asphyxiation hazards. Medline cited possible overheating under certain conditions and risks linked to accessories, lying on a pendant or using loose or wobbly rails. The FDA says Medline reported two deaths and 16 serious injuries associated with the issues as of October 20, 2026.
Source: fda.gov
