Device recall

Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E MDR520094 PENDANT F/ MDR107003E MDR530094 PENDANT, W/ 9V BATTERY BACKUP, F/ 2E BED MDR540094 PENDANT, W/ 9V BATTERY BACKUP, F/ 3E BED

FDA recall source

Recall number

Z-3227-2026

Event id

99827

Status

Ongoing

FDA classification

Class I

Recalling firm

Medline Industries, LP

Report date

Oct 7, 2026

Posted

Oct 1, 2026

Initiated

Aug 14, 2026

Center classification date

Sep 30, 2026

Product code

LLI

Device type

Bed, Therapeutic, Ac-Powered, Adjustable Home-Use

Reason

Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire. Additional products added to 11/26/2025 recall.

Root cause

Device Design

Quantity

771,127 total

Code info

MDR510094 UDI-DI 10888277363021 MDR520094 UDI-DI 10884389161692 MDR530094 UDI-DI 10197344119059 MDR540094 UDI-DI 10197344119066 All lots

Distribution

Distribution US Nationwide including territories of Puerto Rico and Guam and the countries of Bermuda, Canada, and Panama.

Voluntary or mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States