Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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.) and recall number D-0512-2026, then follow Fresenius Medical Care Holdings, Inc.'s recall.

Recall Record: Class II Recall: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe… by Fresenius Medical Care Holdings, Inc.

Here's the summary: Fresenius Medical Care Holdings, Inc. recalled 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. on 2026-05-13. FDA classified this action as a Class II recall (recall number D-0512-2026). Reason for recall: Lack of Assurance of Sterility: Potential leaks from perforations in bags.. Recall status: Ongoing. This is a drug-category FDA recall record.

Key facts

Recalling firm	Fresenius Medical Care Holdings, Inc.
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	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.
Classification	Class II
Recall number	D-0512-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Lack of Assurance of Sterility: Potential leaks from perforations in bags.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with 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. -- and the recall number D-0512-2026. If it matches, stop using or distributing it and contact Fresenius Medical Care Holdings, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Fresenius Medical Care Holdings, Inc. and the affected product is described in FDA's record as: 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.. FDA's stated reason for the recall is: Lack of Assurance of Sterility: Potential leaks from perforations in bags.. The recall is tracked under FDA recall number D-0512-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

Fresenius Kabi USA, LLC’s FDA history

Argus HQ has recorded 22 total FDA actions tied to Fresenius Kabi USA, LLC: 0 warning letters, 22 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
What was recalled and why?: Fresenius Medical Care Holdings, Inc. recalled 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.. FDA's record states the reason for recall as: Lack of Assurance of Sterility: Potential leaks from perforations in bags.. The recall is logged under FDA recall number D-0512-2026 with a Class II classification.
How serious is this recall?: FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
What should someone who has this product do?: Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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.) and recall number D-0512-2026, then follow Fresenius Medical Care Holdings, Inc.'s recall.

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Full FDA history for Fresenius Kabi USA, LLC

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Recall Record: Class II Recall: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe… by Fresenius Medical Care Holdings, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-fresenius-medical-care-holdings-inc-d-0512-2026

MLA

"Recall Record: Class II Recall: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe… by Fresenius Medical Care Holdings, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-fresenius-medical-care-holdings-inc-d-0512-2026.

Chicago

Argus HQ Research. "Recall Record: Class II Recall: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe… by Fresenius Medical Care Holdings, Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-fresenius-medical-care-holdings-inc-d-0512-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_fresenius_medical_care_holdings_inc_d_0512_2026_2026,
  title = {Recall Record: Class II Recall: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe… by Fresenius Medical Care Holdings, Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-fresenius-medical-care-holdings-inc-d-0512-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗