FreshRecalls

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FDAClass II · Drug · Recalled May 13, 2026

DELFLEX recall — Fresenius Medical Care Holdings, Inc.

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0513-2026
Brand
Fresenius Medical Care Holdings
Classification
Class II
Units affected
43,225 bags
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

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.

Affected products

Companies & origin

Recalling firm location
Waltham, MA, United States
Firm address
920 Winter St Bld 920, 02451-1521

Identifying details (verbatim from the notice)

Product codes / lots
Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013
Distribution
Nationwide in the USA
Firm notified the public via
Letter
FDA event ID
98829
Recall initiated
April 6, 2026
FDA classified
May 4, 2026
FDA report date
May 13, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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