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Device Description | Item Number | UDI-DI |
|---|---|---|
| Medline Basic Bed, Semi Electric | MDR107002E | 40080196320999 |
| Medline Basic Bed, Semi Electric, Four Pack | MDR107002E-4 | 40080196320999 |
| Medline Basic Bed, Full Electric | MDR107003E | 40080196321002 |
| Medline Basic Bed, Full Electric, Four Pack | MDR107003E-4 | 40080196321002 |
| Medline Basic Bed, Low Full Electric | MDR107003ELO | 10080196546992 |
| Medlite Homecare Bed, Semi Electric | MDR107002L | 40080196294320 |
| Medlite Homecare Bed, Basic, Full Electric | MDR107003L | 40080196294344 |
| Medlite Homecare Bed, Low Full Electric, Basic | MDR107003LO | 40080196325901 |
For Medline Basic Beds and Medlite Homecare Beds identified above, only use accessories intended for use with Medline Homecare Beds, the agency said.
On November 26, Medline sent all affected customers a letter recommending the following actions:
Medline has identified electrical safety risks with its Medline Basic Homecare Beds that may lead to fire.
The electrical safety risk is a potential hazard involving the hand control pendant and associated wires for Medline Basic Homecare Beds, SKUs MDR107002E, MDR107002E-4, MDR107003E, MDR107003E-4, and MDR107003ELO. In certain scenarios—such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor, among other potential conditions—the hand pendant and pendant cords may overheat and, in some instances, pose a risk of fire. Medline Industries has received reports of pendants sparking, burning, melting, smoking, and catching on fire.
As of December 18, Medline has reported 12 injuries and one death associated with this issue.
Additionally, Medline has identified patient entrapment as a potential issue when using non-Medline accessories on Medline beds. Non-Medline accessories or a user error when handling the pendant can unintentionally cause the bed to adjust position, entrapping the user’s body between the bed and the accessory. Entrapment could lead to asphyxiation, serious injury, and death. Patients with reduced monitoring, such as those at home, are at increased risk due to delays in detecting and responding to entrapment incidents.
As of December 18, Medline has reported two injuries and one death associated with the use of non-Medline approved accessories.
An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. Hospital beds include side rails that can be latched on or off and moved around.
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Medline Industries at 866-359-1704 or recalls@medline.com.
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
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