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FDA early alert: Medline beds and accessories

FDA’s device-safety listing identifies an October 29 early alert concerning Medline-brand beds and associated products. A subsequently viewed FDA alert describes electrical overheating and fire risks as well as separate entrapment or asphyxiation risks associated with accessories, a pendant or loose rails. FDA says all Medline-brand beds and associated components are affected, including home-care, bariatric and long-term-care beds. FDA reports that covered beds, rails, mattresses and accessories may remain in use under the updated instructions until the bed is repaired or replaced. The later-observed precautions include unplugging beds except when needed for repositioning, avoiding extension cords and, whenever possible, having a second person assist with use and movement. FDA advises against repairing, modifying or altering a bed except through the specified Medline-authorized process.

Generic care bed illustration
Illustrative artwork; not evidence of the actual people, products or events described.

Applicability and suggested action: Equipment owners, clinical, facilities and biomedical teams should identify affected products and consult the complete current FDA and manufacturer instructions. The FDA page and Medline’s October 24 update were reviewed on November 2; the exact October 31 page version is not represented. Medline describes eligibility for repair, replacement or a full or partial refund for certain purchases within five years. Products purchased more than five years ago remain subject to the field action and precautions.

FDA Medline early alert | Medline October 24 update | FDA affected-products list

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