Semi electric lightweight homecare beds recalled over pendants that may overheat
Medline is recalling 13,245 Semi Electric Lightweight Homecare Beds because the hand control pendant and its cords may overheat and, in rare instances, pose a risk of fire.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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 Lightweight Homecare Bed, REF MDR107002L, 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 13,245 units under UDI/DI 40080196294320, 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
- MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Homecare bed
- Affected units
- 13,245
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 40080196294320
- All lots
Distribution
Part of a larger recall action
This product is one of 6 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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