Semi electric homecare beds recalled over hand pendants that may overheat
Medline is recalling 373,392 units of the Semi Electric Basic Homecare Bed because the hand control pendant and its cords may overheat and, in rare instances, pose a risk of fire.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
Medline beds labeled as Semi Electric Basic Homecare Bed, REF MDR107002E, and Semi Electric Basic Homecare Bed 4-pack, REF MDR107002E-4 are being recalled by Medline Industries, LP.
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. The firm states that 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 or motor, the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline states it has received a total of 58 complaints associated with reports of pendant sparking, burning, melting, smoking or fire.
The record lists 373,392 units under UDI/DI 40080196320999, all lots. Distribution covered the US, California, Pennsylvania, Guam and the US Virgin Islands as listed in the record. The FDA has classified the action as Class I, its most serious category.
Users and caregivers should follow Medline's instructions, including any guidance on operating within the bed's specified weight limit and on inspecting the pendant and its cord.
The recalled product
- Product
- Mikario Trading 5-in-1 Convertible Baby Gyms
- Manufacturer
- Ningbo Resoul Digital Technology Co., Ltd., of China
- Category
- Medical Device — Homecare bed
- Hazard
- overheating
- fire-risk
- hand-pendant
- class-i
- Affected units
- 500
Distribution
Distributed nationwide across the United States.
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