DELFLEX — Class II drug recall D-0512-2026
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2026-05-13, distributed nationwide. Lack of Assurance of Sterility: Potential leaks from perforations in bags.
| Recall number | D-0512-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2026-04-06 |
| Classified | 2026-05-04 |
| Reported by FDA | 2026-05-13 |
| Distributed | Nationwide (US) |
| Quantity | 37,215 bags |
| Reason classes | sterility, packaging |
| Lot numbers | 25CU02007, 25CU02008, 25CU02009 |
| Model numbers | 054-20221 |
Product
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Reason for recall
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0512-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.