DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-s…
Recalled by Fresenius Medical Care Holdings, Inc.
Drug recall
Fresenius Medical Care Holdings, Inc.
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Fresenius Medical Care Holdings, Inc. has recalled DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-s…, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on May 13, 2026 and was initiated on April 6, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-s…, with approximately 43,225 bags affected. The company behind the recall is Fresenius Medical Care Holdings, Inc., based in Waltham, MA. The FDA describes the product as: “DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.”
Why was DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-s… recalled?
According to the FDA, the stated reason for the recall is: “Lack of Assurance of Sterility: Potential leaks from perforations in bags.” In plain terms, this recall relates to a sterility or contamination concern.
Sterile medicines, such as injectables and eye drops, must be completely free of microorganisms and stray particles. This recall means that sterility could not be assured or that contamination was found or suspected. Using a non-sterile product of this kind can cause infections, which is why these recalls are treated seriously.
What should you do?
If you think you may have bought DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-s…, compare it against the product description and identifying codes (Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Fresenius Medical Care Holdings, Inc. or your local health authority.
About this recall
This recall was distributed in MA. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- May 13, 2026
- Recall started
- April 6, 2026
- Distributed in
- MA
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-s… recalled?+
According to the FDA: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-s…?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0513-2026. Information last synced from the FDA on July 5, 2026.