Z-3227-2026 Class I Ongoing
FDA device recall Z-3227-2026 was initiated by Medline Industries, LP on Aug 14, 2026 and is designated Class I. 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… The recall status is ongoing. Affected quantity: 771,127 total.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 7, 2026
- Initiation Date
- Aug 14, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
Code Information
MDR510094 UDI-DI 10888277363021 MDR520094 UDI-DI 10884389161692 MDR530094 UDI-DI 10197344119059 MDR540094 UDI-DI 10197344119066 All lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3227-2026
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026