FDA Device Recall Z-1012-2026

Medline Industries, LP · Northfield, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L

Lot / serial / GTIN: UDI/DI 40080196294320, All lots

Quantity: 13245 units

Reason for recall

Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.

Recall record

Recall number: Z-1012-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US, CA, PA, GUAM, VI
Recall initiated: 2025-11-26
Classified by FDA Center: 2026-01-16
FDA published: 2026-01-28
Recalling firm: Medline Industries, LP
Firm location: Northfield, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All device recalls