Fresenius Medical Care Holdings, Inc.: FDA regulatory profile

Fresenius Medical Care Holdings, Inc. appears in 2 indexed U.S. FDA records: 2 recall records, naming 1 distinct product. Latest dated event: a recall record dated 2026-05-13. Observations run 2026-05-13 to 2026-05-13, 2 dated records across 1 calendar year, busiest 2026 with 2. Recalls: 2 Class II (100%); 2 ongoing by lifecycle status, reported 2026-05-13; 2 with an FDA recall number, 2 with an initiation date, across 1 state, grouped into 1 FDA recall event. Every figure here is a count or a date computed from the indexed FDA datasets over a finite window: coverage-limited activity signals, never quality ratings or judgements about the firm. Recall records: DELFLEX (D-0512-2026, Class II, 2026-05-13) and DELFLEX (D-0513-2026, Class II, 2026-05-13). Recalling-firm addresses are recorded in MA. Its recall lines are grouped by the FDA into 1 event identifier: 98829. Distribution is recorded in the source as Nationwide in the USA. Recalling-firm country of record: United States. Recall initiation dates run 2026-04-06 across 2 records. This firm appears in 2 indexed records, which is below the threshold this site requires before treating a manufacturer page as a standalone regulatory profile (only 2 indexed record). The page is published so the record remains reachable and verifiable, and it links on to the underlying FDA records, but it is marked noindex and left out of the sitemap: a single appearance of a company name is not a regulatory history, and presenting it as one would overstate what the data supports. Should further records reference this firm in a later ingestion, the page becomes a full profile automatically.