PharmacovigilanceOfficial

FDA early alert: Medline exits hospital bed market over fire and entrapment risks, two deaths reported

🇺🇸 FDA MedWatch · Thu 29 Oct 2026

Medline is discontinuing all its branded beds and accessories, with repair, replacement or refund offered, after reports of two deaths and 16 serious injuries linked to fire and entrapment hazards.

FDA's device centre has published an Early Alert on Medline's withdrawal from the bed market. Medline sent customers an Urgent Medical Device Field Safety Notice on 14 October 2026 announcing the discontinuation and exit of all Medline-brand beds, plus their pendants, accessories, replacement parts and order packages containing beds. The affected range spans homecare, bariatric and long-term care beds. Medline recommends removing the products from use or sale or, in some cases, correcting them before further use.

The company issued updated recommendations on 24 October. Beds, rails, mattresses and accessories may stay in use until the bed is repaired or replaced, provided users follow new instructions. Beds should be unplugged and connected to power only while a patient is being repositioned. Extension cords must not be used, and a second person should assist with bed use and movement where possible. Users should not repair or modify beds unless Medline's authorised repair process instructs them to do so.

Medline is setting up two routes. Some beds may be repaired and then used according to their Instructions for Use. Where a bed or accessory is ineligible for repair, Medline will work with customers on replacement or a full or partial refund of the purchase price. Remedies may be available for products bought in the last five years, but items older than that remain subject to the field action and the interim instructions. Customers can reach Medline Recall Customer Service on 1-800-950-0128, option 7.

FDA describes a fire hazard involving beds, hand-control pendants, control or motor boxes, and actuators or motors. Conditions listed include excessive loading, jammed components or motors, damage to or fluid ingress into the pendant, extension cord use, and non-Medline or unapproved pendants or accessories. Overheating could progress to smoking, sparking, melting, burning or fire, with risks of electrical shock, burns, smoke-related chronic respiratory conditions, PTSD or death.

A separate issue concerns entrapment or asphyxiation. Post-market surveillance showed a risk when beds are used with any bed accessories, when a user lies on a pendant in use, or when rails are loose or wobbly. As of 20 October 2026, Medline had reported two deaths and 16 serious injuries tied to these issues. Adverse events should go to Medline (QualityAssurance@medline.com or 1-800-950-0128, option 5) and to FDA MedWatch. FDA is still reviewing the matter and says it will update its page.

What it means for your team

  • Facilities and home-care providers should inventory Medline-brand beds, pendants, rails, mattresses and accessories and check them against the full affected-product list.
  • Implement the interim controls now: unplugging beds when not repositioning patients, no extension cords, a second person assisting where possible, and no unauthorised repairs or modifications.
  • Pharmacovigilance and quality teams should route any fire, overheating or entrapment events to both Medline and FDA MedWatch, and keep records of beds bought over five years ago, which fall outside the remedy window but remain subject to the field action.
  • Procurement and risk teams should plan for replacement capacity, as Medline is leaving the bed market and remedies depend on repair eligibility.

Official source: FDA MedWatch ↗

Article written by VigiEye from the official source (FDA MedWatch). AI-assisted; check the source before acting.

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