Stop using now Drug recall · FDA · Published April 6, 2026

Fresenius Recalls DELFLEX Dialysis Bags Due to Sterility Risk

Fresenius Medical Care recalls specific lots of DELFLEX Dextrose Peritoneal Dialysis Solution due to potential leaks from bag perforations.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0513-2026Drug Fresenius Medical Care ›

Stop using this now

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

Take action

Contact the company

Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 920 · Waltham, MA 02451-1521

✎ GovInfoNow plain-language explainer

Fresenius Medical Care Holdings, Inc. is recalling DELFLEX Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only. The recall affects 2.5% DEX formulations in 2L packs (Part Number 054-20222) distributed nationwide. The issue stems from a lack of assurance of sterility caused by potential leaks from perforations in the bags. Read more at govinfonow.com/recall/31363-fresenius-recalls-delflex-dialysis-bags-due-to-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31363-fresenius-recalls-delflex-dialysis-bags-due-to-sterility-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0513-2026

Cite this page

“Fresenius Recalls DELFLEX Dialysis Bags Due to Sterility Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/31363-fresenius-recalls-delflex-dialysis-bags-due-to-sterility-risk. Based on FDA recall #D-0513-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0513-2026%22&limit=1).

Fresenius Medical Care Holdings, Inc. voluntarily recalled DELFLEX Dextrose Peritoneal Dialysis Solution due to potential leaks from perforations in bags that compromise sterility assurance, according to the FDA on April 6, 2026.

How to tell if you have it

Brand: Fresenius Medical Care
Product: DELFLEX Dextrose Dialysis Solution
Part Number: 054-20222
Lots: 25CU02002, 25CU02011, 25CU02012, 25CU02013

The hazard

The recall addresses a lack of assurance of sterility caused by potential leaks from perforations in the bags.

Context

GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since April 14, 2014. Other recent recalls include a Fresenius Bicarby Dialysate recall for slip and fall hazards on May 12, 2026, and a Fresenius 5008X Blood Tubing Set recall for online port errors on May 11, 2026. Similar recent recalls of similar products include Fresenius Kabi 5% Dextrose Injection, Fresenius Kabi 0.9% Sodium Chloride Injection, and Fresenius Kabi 500mL Sodium Chloride Injection, all for lack of sterility assurance on March 11, 2026.

How to tell if you have this one

Check your product packaging for the brand name DELFLEX and Part Number 054-20222. Verify if your specific lots are among the recalled numbers: 25CU02002, 25CU02011, 25CU02012, or 25CU02013.

Brand
Fresenius Medical Care
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide in the USA

Recall number	Product, codes & lots	Quantity
D-0512-2026	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.; Lot #: 25CU02007, 25CU02008, 25CU02009	37,215 bags
D-0513-2026	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.; Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013	43,225 bags

Based on the official FDA remedy

What to do — step by step

Stop Using Affected Bags
Do not use the recalled DELFLEX Dextrose Peritoneal Dialysis Solution bags due to sterility risks.
Contact Manufacturer
Reach out to Fresenius Medical Care North America at 920 Winter Street, Waltham, MA 02451 for further instructions or remedies.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 37 days after the firm started it.

Apr 6, 2026Firm started the recall
May 4, 2026FDA classified it Class II
May 13, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31363-fresenius-recalls-delflex-dialysis-bags-due-to-sterility-risk">Fresenius Recalls DELFLEX Dialysis Bags Due to Sterility Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0513-2026 (April 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0513-2026 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.