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U.S. Department of Health and Human Services

Class 1 Device Recall Medline

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 Class 1 Device Recall Medlinesee related information
Date Initiated by FirmNovember 26, 2025
Date PostedJanuary 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1012-2026
Recall Event ID 98185
Product Classification Bed, therapeutic, ac-powered, adjustable home-use - Product Code LLI
ProductMEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L
Code Information UDI/DI 40080196294320, All lots
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
866-359-1704
Manufacturer 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 pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.
FDA Determined
Cause 2		Device Design
ActionMedline issued an URGENT MEDICAL DEVICE RECALL notice with an enclosed URGENT MEDICAL DEVICE FIELD CORRECTION NOTICE to its consignees on 11/26/2025 via email and USPS first class mail. The notice explained the issue, potential risks, and requested the user ONLY USE MEDLINE SIDE RAILS and MEDLINE ACCESSORIES that are intended for use with Medline Homecare Beds. When using Medline Side Rails and Medline Accessories, follow all applicable instructions for use. Distributors were directed to notify their customers. For questions, contact the Recall Department at 866-359-1704 orrecalls@medline.com.
Quantity in Commerce13245 units
DistributionUS, CA, PA, GUAM, VI
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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