The FDA has posted 9 enforcement recalls of dialysate concentrate for hemodialysis (liquid or powder) devices since 2025, none of them Class I (most serious). Most recent report: Sep 16, 2026.
Hemodialysis concentrates contain high endotoxin levels
Hemodialysis concentrates contain high endotoxin levels
Hemodialysis concentrates contain high endotoxin levels
Hemodialysis concentrates contain high endotoxin levels
Complaints of blue-green discoloration in product
Complaints of blue-green discoloration in product
Complaints of blue-green discoloration in product
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in…
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the f…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Dialysate Concentrate For Hemodialysis (Liquid Or Powder)”). Informational only — verify against the FDA before acting.