Medline Class I Device Recall Z-1013-2026 for Beds
Summary
The FDA has classified a recall by Medline Industries, LP for their Full Electric Basic Homecare Beds as Class I, indicating a potential health hazard. The recall (Z-1013-2026) is ongoing and affects beds distributed in the US and other territories. The issue involves the hand control pendant and associated wires.
What changed
Medline Industries, LP is conducting a Class I device recall (Z-1013-2026) for their Full Electric Basic Homecare Beds due to a potential hazard involving the hand control pendant and associated wires. This recall is classified as Class I by the FDA, signifying that use of or exposure to the affected product may cause serious adverse health consequences or death. The issue arises from potential failure of the hand control pendant and wires under specific, atypical conditions such as exceeding the weight limit or encountering obstructions.
Companies that have distributed these beds, particularly in the US, Canada, Pennsylvania, Guam, and the Virgin Islands, must ensure they have implemented Medline's recall procedures. While the document does not specify a compliance deadline, affected parties should review Medline's recall instructions and take appropriate action to mitigate risks to patients. Failure to comply with recall procedures could result in further regulatory action from the FDA.
What to do next
- Review Medline's recall procedures for affected beds.
- Take appropriate action to mitigate risks to patients.
Source document (simplified)
Medline Industries, LP
Device Recalls (Class I)
← All Device Recalls (Class I) Class I Z-1013-2026 · 20260128 · Ongoing
Product
MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pack,REF MDR107003E-4.
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 pe...
Distribution
US, CA, PA, GUAM, VI
Source: openFDA Enforcement API
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