Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E
Summary
The FDA issued a Class I for Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pend by Medline Industries, LP. Reason: Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potent.
Details
Source
Device Recall
External ID
Z-3227-2026
Action Date
2026-10-07
Status
Ongoing
Category
device
Product Description
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E MDR520094 PENDANT F/ MDR107003E MDR530094 PENDANT, W/ 9V BATTERY BACKUP, F/ 2E BED MDR540094 PENDANT, W/ 9V BATTERY BACKUP, F/ 3E BED
Lot/Code Info: MDR510094 UDI-DI 10888277363021 MDR520094 UDI-DI 10884389161692 MDR530094 UDI-DI 10197344119059 MDR540094 UDI-DI 10197344119066 All lots
Quantity Affected: 771,127 total
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.
Distribution
Distribution US Nationwide including territories of Puerto Rico and Guam and the countries of Bermuda, Canada, and Panama.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-14
Company
Northfield, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 238 device recalls issued in the same week, part of 518 device-related FDA actions this month.
Medline Industries, LP has 584 FDA actions in our database, including 555 recalls and 29 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 584 FDA actions in our database, including 555 recalls and 29 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3227-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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