CLASS II ONGOING Drug recall · Reported 13 May 2026 · FDA Enforcement Report

Delflex, Dextrose Peritoneal Dialysis Solution recalled

Fresenius Medical Care Holdings is recalling Delflex, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for, distributed nationwide in the US. The recall was initiated on 6 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 25CU02007, 25CU02008, 25CU02009

Quantity recalled37,215 bags

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0512-2026
FDA event ID: 98829
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class II
Status: Ongoing
Recall initiated: 6 Apr 2026
FDA classified: 4 May 2026
Reported: 13 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

6 Apr 2026	Recall initiated by company
4 May 2026	Classified by FDA	+28 days
13 May 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot #: 25CU02007, 25CU02008, 25CU02009

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98829

This product is part of a recall event; the main page for the event is Delflex, Dextrose Peritoneal Dialysis Solution recalled.

Reported	Class	Recall	Company	Reason	Where
13 May 2026	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide

More recalls from Fresenius Medical Care Holdings

All 165

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	5008X Blood Tubing Set recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
17 Jun 2026Device	CLASS II	Bicarby" Dialysate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
17 Jun 2026Device	CLASS II	Bicarby Dialysate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	TX
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide
24 Dec 2025Device	CLASS II	5008X CAREsystem +CLiC +CDX recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Device Malfunction	LA, MA, MN

Other Delflex recalls

All 2

Reported	Class	Recall	Company	Reason	Where
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide