DELFLEX, 2.5% recall — Fresenius Medical Care Holdings, Inc. (Class II)

Regulatory snapshot

Reason reported by FDA

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

11 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.

Product identifiers in this record

3 identifying values matched by exact pattern in the 33-word product description above; each is a literal substring of it.

Which configuration this record is

2 recall numbers share event 98829. They differ on strength and agree on everything else the source states, so those are the values to check a package against.

Shared across all 2 records under this event: form Solution; product named DELFLEX; fda tier Class II; recalling firm Fresenius Medical Care Holdings, Inc.; the same reason text; initiated 2026-04-06; reported 2026-05-13.

Reading this record

Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. A search on event 98829 returns all 2 of these recall numbers; a search on D-0513-2026 returns only this configuration.

Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Fresenius Medical Care Holdings, Inc. (2 indexed records) aggregates this firm across datasets.

• What a Class II recall means
• What "Ongoing" recall status means
• How to monitor a manufacturer’s recall history
• FDA recall classifications: Class I, II and III

Coverage and limits of this record

This page reflects the openFDA enforcement report for D-0513-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.