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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 FirmAugust 14, 2026
Date PostedOctober 01, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3228-2026
Recall Event ID 99827
Product Classification Bed, manual - Product Code FNJ
ProductMedline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE
Code Information MDR107000P UDI-DI 00080196288284 All lots
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
800-633-5463
Manufacturer Reason
for Recall		Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire. Additional products added to 11/26/2025 recall.
FDA Determined
Cause 2		Device Design
ActionFirm initially notified customers November 26, 2025. On August 14, 2026, the firm sent a follow-up letter which provides additional product SKU - Item numbers for the electrical system safety risks and additional important information related to the previous notices. 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 Commerce771,127 total
DistributionDistribution US Nationwide including territories of Puerto Rico and Guam and the countries of Bermuda, Canada, and Panama.
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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