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The FDA issued an Early Alert about a potentially high-risk issue affecting all Medline Brand beds and related components. Medline’s October 24 update says affected beds may remain in use under specified precautions while repair, replacement or refund options are assessed. As of October 20, Medline had reported two deaths and 16 serious injuries associated with the identified hazards.
The U.S. Food and Drug Administration has issued an Early Alert covering all Medline Brand beds and associated pendants, rails, mattresses, accessories, replacement parts and bed-containing order packages, citing potential fire and entrapment hazards. Medline’s updated October 24, 2026, instructions allow affected beds to remain in use under specified precautions while the company determines whether they can be repaired or should be replaced or refunded.
The FDA says Medline identified a potential fire hazard involving electrical components, including hand-control pendants, control or motor boxes, and actuators or motors. Under certain conditions, the components may overheat and progress to smoking, sparking, melting, burning or fire. Factors cited include excessive system loading, jammed components or motors, damage to a pendant or fluid entering it, extension-cord use, and unapproved pendants or accessories.
The agency also describes a separate entrapment or asphyxiation risk linked to bed accessories, a user lying on a pendant, or loose or wobbly rails. The FDA says these hazards may cause serious injury or death. As of October 20, 2026, Medline had reported two deaths and 16 serious injuries associated with the issues. The alert does not provide further case details in the supplied notice.
Medline notified affected customers on October 14 and issued modified guidance on October 24. The updated instructions say users should unplug affected beds when they are not being adjusted. For necessary repositioning, plug the bed in only while making the adjustment, then unplug it. Do not use extension cords; when possible, have a second person assist with using and moving the bed. Users should not attempt repairs or modifications unless Medline directs them through an authorized repair process.
Safety Steps for Bed Users
The alert applies across homecare, bariatric and long-term-care beds, as well as related products and packages. That range means the notice may affect patients, caregivers, care facilities and product purchasers, not only one model or setting. The FDA’s warning describes hazards that could involve fire, electrical shock, burns, entrapment or asphyxiation.
The updated notice sets out a temporary course of action rather than instructing every customer to stop using the beds immediately: affected products may remain in use under the revised precautions until repair or replacement. Customers should contact Medline to identify the applicable process and product status. The agency’s reported injury and death figures underline the seriousness of the alert, but the notice does not establish how frequently the events occurred or the circumstances of each report.
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How Medline’s Guidance Changed
Medline’s October 14, 2026, customer notice covered discontinuation and market exit for all Medline Brand beds and associated products, recommending removal from locations where they were used or sold, or correction in some cases before continued use. The FDA subsequently summarized an October 24 update that changed the instructions for current users: qualifying beds may stay in use under specified precautions while Medline evaluates repair, replacement or refund options.
Medline’s notice describes two paths for affected beds: repair for beds deemed eligible, or replacement or a full or partial refund of the original purchase price when Medline determines repair is not an option. These remedies may be available for certain beds, rails, mattresses and accessories purchased within the past five years. Products bought more than five years ago remain subject to the field action and updated safety instructions, the FDA says.
The FDA describes its communication as an Early Alert for a potentially high-risk device issue and says it is reviewing information. The alert covers product categories including homecare beds, bariatric beds and long-term-care beds, along with pendants, accessories, replacement parts and bed-containing order packages. The full affected-product list and Medline’s customer notice are referenced by the FDA.
“Do not use extension cords to power the bed.”
— Medline, in the updated customer instructions summarized by the FDA
Details Still Under Review
The FDA says it is reviewing information and will update its alert as significant new details become available. The notice does not specify the models or serial numbers involved in the supplied material, describe the circumstances of the reported deaths and injuries, or state how many customers or devices are affected. Readers should use the FDA’s affected-product list and contact Medline to confirm whether a specific bed or component is covered.
It is also not clear from the alert how quickly Medline will complete repairs, replacements or refunds, or what criteria will determine eligibility for each option. The notice says some products may qualify for a remedy if purchased within the past five years; it does not promise that every product within that period will receive one. The supplied FDA page does not give a final timeline for the company’s market exit or the agency’s review.
Contact Medline and Watch FDA Updates
Customers with potentially affected products should contact Medline Recall Customer Service at 1-800-950-0128, option 7, to ask about product coverage and start the repair, replacement or refund process. The FDA also directs users to Medline’s recall page for updated information. Users should follow the updated operating instructions and avoid unauthorized repairs.
Report adverse events to Medline at QualityAssurance@medline.com or 1-800-950-0128, option 5, and to the FDA’s MedWatch program, according to the alert. The FDA says it will post significant new information as it continues reviewing the issue; no further agency decision or completion date is specified in the notice.
Key Questions
Which Medline products are covered by the alert?
The FDA says the action covers all Medline Brand beds and associated pendants, rails, mattresses, accessories, replacement parts and bed-containing order packages, including homecare, bariatric and long-term-care beds. Check the FDA’s affected-product list or contact Medline to verify a specific item.
Can affected beds still be used?
Medline’s October 24 instructions, as summarized by the FDA, say affected beds may remain in use under specified precautions until repaired or replaced. Users should unplug the bed except when making necessary adjustments, avoid extension cords and follow the full instructions from Medline.
What hazards prompted the FDA alert?
The alert describes possible overheating and fire involving bed electrical components, and possible entrapment or asphyxiation associated with accessories, pendants or loose rails. The FDA says these events may cause serious injury or death.
How can customers ask about a repair or refund?
Contact Medline Recall Customer Service at 1-800-950-0128, option 7. Medline says certain beds may be eligible for repair; products it determines are not repairable may be considered for replacement or a full or partial refund, subject to eligibility.
Source: fda.gov
