The FDA has posted 9 enforcement recalls of high permeability with or without sealed dialysate system dialyzer devices since 2025, none of them Class I (most serious). Most recent report: Sep 2, 2026.
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Dialyzer, High Permeability With Or Without Sealed Dialysate System”). Informational only — verify against the FDA before acting.