Fresenius Medical Care North America Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Distributed by Fresenius USA Inc., Walnut Creek, CA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Distributed by Fresenius USA Inc., Walnut Creek, CA
Brand
Fresenius Medical Care North America
Lot Codes / Batch Numbers
Catalog Numbers 190011 (60 Hz main power supply), 190092 (50 Hz main power supply), 150425 (AC power cord assembly -hemodialysis machine) and 160089 (AC power cord assembly, Granuflo 1 mixers)
Products Sold
Catalog Numbers 190011 (60 Hz main power supply), 190092 (50 Hz main power supply), 150425 (AC power cord assembly -hemodialysis machine) and 160089 (AC power cord assembly, Granuflo 1 mixers)
Fresenius Medical Care North America is recalling Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and G due to Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.
Recommended Action
Per FDA guidance
An urgent device recall notification was sent to all consignees. Customers are asked to inspect cords for defects, and are refered to preventive maintenance requirements in the manual. Customers who identify the defective cords will be instructed to discontinue use as soon as possible without jeopardizing patient care. Customers are instructed to monitor cords regularly, and pay attention to machines that are frequently plugged or unplugged. Personnel are instructed to not use the cord to unplug the device from the wall (yanking the plug from the wall) and to refrain from rolling over the cord or plug.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026