Changeflow GovPing Healthcare Medline Class I Device Recall Z-1013-2026 for Beds
Urgent Enforcement Amended Final

Medline Class I Device Recall Z-1013-2026 for Beds

Favicon for changeflow.com FDA: Device Recalls Class I
Filed January 28th, 2026
Detected March 27th, 2026
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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

  1. Review Medline's recall procedures for affected beds.
  2. 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

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
January 28th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Z-1013-2026

Who this affects

Applies to
Consumers Healthcare providers Manufacturers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Device Recalls
Geographic scope
United States US

Taxonomy

Primary area
Product Safety
Operational domain
Compliance
Topics
Medical Devices Consumer Protection

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