PharmacovigilanceOfficial

Medline details repair and replace programme for recalled beds, rails, mattresses and accessories

🇺🇸 FDA MedWatch · Fri 13 Nov 2026

Medline has updated guidance on continued use and remedies for all its branded beds and accessories, recalled over fire and entrapment risks linked to seven deaths and 35 serious injuries.

Medline has published an update on its recall, market exit and discontinuation of all Medline Brand beds, rails, mattresses and accessories, including pendants and motor boxes. The action began on 14 October 2026 and concerns a potential fire hazard and entrapment risk that may lead to patient injury or death. The US Food and Drug Administration posted the company announcement on 13 November 2026.

As of 8 November 2026, Medline had received reports of seven deaths and 35 serious injuries associated with these issues. The products were distributed in the United States and Canada between 2011 and 2026 to durable medical equipment providers, long-term care facilities and directly to end users. The recall covers all Medline Brand beds and associated rails, mattresses and accessories on the market.

Customers were first notified by letter on 14 October, and updated letters followed on 24 October with revised instructions for continued use and remedy options. Recalled beds may stay in use until they are repaired or replaced, provided users follow the updated instructions. Beds should be unplugged from electrical outlets straight away. When adjustments are needed, the bed may be plugged in while the patient is repositioned and unplugged again afterwards. Extension cords must not be used, and a second person should assist with use and movement of the bed where possible.

Under the repair and replace programme, certain existing beds may be eligible for repair and can then be used in line with their Instructions for Use. Where beds and accessories cannot be repaired, Medline says it will work with customers to assess eligibility for replacement or a full or partial refund of the original purchase price. Remedies may be available for certain items bought in the past five years. Users are told not to repair, modify or alter the beds unless instructed through a Medline-authorised repair process.

Medline says it will soon start distributing visual repair and replace Customer Guides to patients and users, with product SKUs and label instructions published on its recall web page. Eligibility checks should go through the provider or distributor that supplied the bed, or through Medline Recall Customer Service on 800-950-0128, option 7, for direct purchasers. Adverse events and quality problems can be reported to the FDA's MedWatch programme.

What it means for your team

  • Long-term care operators and DME providers should confirm that the interim safety instructions (unplugging beds, no extension cords, second person assisting) are being applied while beds remain in use.
  • Quality and complaint-handling teams should check inventories against the SKU and label information on Medline's recall page and track eligibility for repair, replacement or refund, which may cover purchases from the last five years.
  • Pharmacovigilance and device-vigilance staff at affected facilities should report related adverse events or quality problems to FDA MedWatch.
  • The remedy is limited to repairs through Medline-authorised processes; unauthorised modification of the beds is explicitly discouraged.

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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