FDA posted an early alert on October 29 covering every Medline brand bed and its accessories. Medline reported two deaths and 16 serious injuries as of October 20. Electrical components can overheat, which can lead to smoking, sparking, melting, burning or fire. A separate entrapment and asphyxiation risk applies when beds are used with accessories, when a user lies on a pendant, or when rails are loose.
The scope is the whole line: homecare, bariatric and long-term care beds, pendants, accessories, replacement parts and order packages that contain a bed. Medline sent an urgent field safety notice on October 14 announcing product removal, discontinuation and exit from the market.
An updated notice on October 24 lets affected beds stay in use under new instructions until repair or replacement. Medline tells users to unplug the bed except when repositioning a patient, skip extension cords, and use a second person where possible. Some beds can be repaired, others get a replacement or a full or partial refund, and eligibility is limited to items bought in the last five years. Users are told not to repair or modify a bed unless Medline authorizes the process.
FDA has not classified the recall. An early alert is what the agency issues ahead of classification when it judges a device problem high risk. Medline announced the market exit two weeks before the alert posted.