Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR51009...

FDA Device Recall #Z-3227-2026 - Class I, August 14, 2026

Recall Summary

Recall Number Z-3227-2026
Classification Class I - Serious risk
Date Initiated August 14, 2026
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medline Industries, LP
Location Northfield, IL
Product Type Devices
Quantity 771,127 total

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

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 Pattern

Distribution US Nationwide including territories of Puerto Rico and Guam and the countries of Bermuda, Canada, and Panama.

Lot / Code Information

MDR510094 UDI-DI 10888277363021 MDR520094 UDI-DI 10884389161692 MDR530094 UDI-DI 10197344119059 MDR540094 UDI-DI 10197344119066 All lots

Other Recalls from Medline Industries, LP

Recall # Classification Product Date
Z-3228-2026 Class I Medline Basic Homecare Beds and Medlite Homecar... Aug 14, 2026
Z-3123-2026 Class I Medline Convenience Kits: 1) PORT ACCESS KIT U... Aug 11, 2026
Z-3124-2026 Class I Medline Convenience Kits: 1) ACC010308A, Catal... Aug 11, 2026
Z-3127-2026 Class I Medline Convenience Kits: 1) DYNDB3086D, Catalo... Aug 11, 2026
Z-3122-2026 Class I Medline Convenience Kits: 1) OPEN HEART ADULT,... Aug 11, 2026

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.