Federal regulators have publicly rebuked one of the world's largest dialysis companies for leaving leaking bags of peritoneal dialysis solution on the market for roughly eight months after its own investigation flagged the problem. The warning letter went to Fresenius Medical Care AG and Co. KGaA, concerns the company's plant in Ogden, Utah, and was posted to the agency's website on September 1, making the internal timeline visible to patients for the first time.
The company opened an investigation in August 2025 after a trend of complaints about leaking bags of DELFLEX Dextrose Peritoneal Dialysis Solution. That review eventually counted 35 complaints covering about 156 bags from multiple batches. No recall followed at that point. Agency investigators inspected the Ogden plant in early March 2026, and the recall came the following month.