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Parker Quality & Compliance

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Device recall

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

FDA recall source

Recall number
Z-3228-2026
Event id
99827
Status
Ongoing
FDA classification
Class I
Recalling firm
Medline Industries, LP
Report date
Oct 7, 2026
Posted
Oct 1, 2026
Initiated
Aug 14, 2026
Center classification date
Sep 30, 2026
Product code
FNJ
Device type
Bed, Manual
Reason
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.
Root cause
Device Design
Quantity
771,127 total
Code info
MDR107000P UDI-DI 00080196288284 All lots
Distribution
Distribution US Nationwide including territories of Puerto Rico and Guam and the countries of Bermuda, Canada, and Panama.
Voluntary or mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States