Fresenius Medical Care's product recalls
5 official recall notices between Jan 2024 and May 2026 were matched to Fresenius Medical Care.
Each notice concerns the specific products, sizes and lot codes it names. A recall does not mean that other Fresenius Medical Care products are affected, and a count of notices is not a measure of safety: one incident can produce a notice for every pack size.
Covers only notices from the U.S. Food and Drug Administration enforcement reports (openFDA), USDA Food Safety and Inspection Service recalls, UK Food Standards Agency food alerts and U.S. Consumer Product Safety Commission recalls that could be matched to Fresenius Medical Care: the recalling firm must be Fresenius Medical Care, a parent or a subsidiary, and for a brand the brand name must appear in the product description. Method.
2026 (2)
| Date | Product | Brand | Recalling firm | Reason given | Source |
|---|---|---|---|---|---|
| DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number… | — | Fresenius Medical Care Holdings, Inc. | Lack of Assurance of Sterility: Potential leaks from perforations in bags. Class II | FDA | |
| DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number… | — | Fresenius Medical Care Holdings, Inc. | Lack of Assurance of Sterility: Potential leaks from perforations in bags. Class II | FDA |
2025 (1)
| Date | Product | Brand | Recalling firm | Reason given | Source |
|---|---|---|---|---|---|
| 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC… | — | Fresenius Medical Care Holdings, Inc. | Lack of Assurance of Sterility Class II | FDA |
2024 (2)
| Date | Product | Brand | Recalling firm | Reason given | Source |
|---|---|---|---|---|---|
| DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess),… | — | Fresenius Medical Care Holdings, Inc. | This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect. Class II | FDA | |
| DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC… | — | Fresenius Medical Care Holdings, Inc. | Lack of Sterility Assurance Class II | FDA |
Product descriptions and reasons are shortened from the regulators' own text; the linked notice is the authoritative record. See all matched recalls, or report a wrong match through the corrections page.