DELFLEX recalled over sterility concerns
- Recall date
- April 6, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Fresenius Medical Care Holdings, Inc. recalls DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only,…
- Recall number
- D-0513-2026
- FDA classification
- Class II
- Brand / firm
- Fresenius Medical Care Holdings, Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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