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Class II · ModerateActive recall

DELFLEX

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots 25CU02002, 25CU02011, 25CU02012, 25CU02013
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forFresenius Medical Care Holdings, Inc.
Show the full FDA record
Full product labelDELFLEX, 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.
Recalling firmFresenius Medical Care Holdings, Inc.
DistributionNationwide in the USA
Quantity43,225 bags
Recall initiated2026-04-06
Report date2026-05-13
Recall completed—
Recall numberD-0513-2026
ClassificationClass II
FDA statusOngoing
Origin on fileWaltham MA United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.