Z-3228-2026

Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE

Name: Z-3228-2026 Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE
Creator: Medline Industries, LP
Published: 2026-08-14
License: https://open.fda.gov/license/

Medline Industries, LP / initiated 2026-08-14 / Open, Classified

FDA source

Recall record

Recall number: Z-3228-2026
Status: Open, Classified
Initiated: 2026-08-14
Posted: 2026-10-01
Recalling firm: Medline Industries, LP
Product: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE
Product code: FNJ Bed, Manual
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 root cause: Device Design
Action: Firm 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 [email protected].
Quantity in commerce: 771,127 total
Distribution: Distribution US Nationwide including territories of Puerto Rico and Guam and the countries of Bermuda, Canada, and Panama.
Product codes and lots: MDR107000P UDI-DI 00080196288284 All lots

Product code FNJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-09. View this recall on fda.gov (opens on fda.gov)