FDAClass IIMay 13, 2026

Delflex recall: Sterility Concern

DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part…

Why was Delflex recalled?

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 25CU02007, 25CU02008, 25CU02009

Product
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part…
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
37,215 bags
Distribution
Nationwide in the USA
Recall date
May 13, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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