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FDA Expands Recall of Fresenius DELFLEX Dialysis Solution Bags

The recall of DELFLEX Dextrose Peritoneal Dialysis Solution has been expanded to include about 156 bags due to potential non-sterility.

4 reports on this incident · first at Sep 9, 2026, 1:02 a.m. ET

By AI ReporterFirst reported Sep 9, 2026, 12:47 a.m. ETWritten Sep 9, 2026, 1:22 a.m. ET
The U.S. Food and Drug Administration (FDA) has expanded the recall of , according to a report from Medical Daily. The recall, initiated on April 1, 2026, now covers of the product, which is manufactured by . The reason for the recall is leaking bags, which could render the drug products potentially non-sterile. No peritonitis case has been attributed to the leaking bags, Medical Daily reported. The recall is . Patients who use DELFLEX are advised to ask their home dialysis nurse to check lot numbers against the company recall announcement and its companion notice, or to search current listings on the FDA's recalls and safety alerts page, according to the report.

Earlier reports

  1. Sep 9, 2026, 1:17 a.m. ET

    FDA Reports Injuries in Ongoing Fresenius DELFLEX Dialysis Solution Recall

    The U.S. Food and Drug Administration has reported injuries or illnesses in connection with the ongoing recall of DELFLEX Dextrose Peritoneal Dialysis Solution, according to Medical Daily. The recall, initiated April 1, 2026, by Fresenius Medical Care AG and Co. KGaA, involves about 156 bags of the product due to leaking bags that could render the drug products potentially non-sterile.

    Medical Daily reports that no peritonitis case has been attributed to the leaking bags. The agency advises patients to ask their home dialysis nurse to check lot numbers against the company recall announcement and its companion notice, or to search current listings on the agency's recalls and safety alerts page.

  2. Sep 9, 2026, 1:08 a.m. ET

    FDA Closes Recall of Fresenius DELFLEX Dialysis Solution Bags

    The U.S. Food and Drug Administration has closed the recall of DELFLEX Dextrose Peritoneal Dialysis Solution bags distributed by Fresenius Medical Care AG and Co. KGaA, according to a report from Medical Daily. The agency considers the recall carried out, the report said.

    The recall, initiated on April 1, 2026, involved about 156 bags of DELFLEX Dextrose Peritoneal Dialysis Solution due to leaking bags that could render the drug products potentially non-sterile. No peritonitis case has been attributed to the leaking bags, Medical Daily reported.

    Patients who still have the product are advised to ask their home dialysis nurse to check lot numbers against the company recall announcement and its companion notice, or search current listings on the agency's recalls and safety alerts page, according to the report.

  3. Sep 9, 2026, 1:02 a.m. ETFirst report

    Fresenius Recalls DELFLEX Dialysis Solution Bags Over Sterility Concern

    Fresenius Medical Care AG and Co. KGaA has initiated a recall of about 156 bags of DELFLEX Dextrose Peritoneal Dialysis Solution, according to a report from Medical Daily. The recall, initiated on April 1, 2026, is due to leaking bags that could render the drug products potentially non-sterile. No peritonitis case has been attributed to the leaking bags, Medical Daily reported.

    The U.S. Food and Drug Administration (FDA) is involved in the ongoing recall, which affects the dialysis solution used by patients. The company advises patients to ask their home dialysis nurse to check lot numbers against the company recall announcement and its companion notice, or to search current listings on the agency's recalls and safety alerts page, according to Medical Daily.

    The cause of the leakage has not been determined, and the recall status remains ongoing.

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Revision history

  1. Version 19 Sept 2026, 05:22current

    First published.

  2. Version 19 Sept 2026, 05:02current

    First published.

  3. Version 19 Sept 2026, 05:17current

    First published.

  4. Version 19 Sept 2026, 05:08current

    First published.

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