The Recall Desk

Manufacturer

Fresenius Medical Care Holdings, Inc.

78 recalls in our database name Fresenius Medical Care Holdings, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–78 of 78

  • LowFDA (Drugs)·D-0606-2021·2021-06-16

    DELFELX Peritoneal Dialysis Solution Recalled Due to Temperature Abuse

    Fresenius Medical Care is recalling 49 cases of DELFELX Peritoneal Dialysis Solution (5000 mL, 4.25% Dextrose) because the product was exposed to temperatures outside specified limits.

    Product
    DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0607-2021·2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recalled Due to Temperature Abuse

    Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (1.5% Dextrose with exchange set) distributed nationwide because the product was exposed to temperatures outside specified limits.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0608-2021·2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recalled for Temperature Exposure

    Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (39 cases nationwide) because the product was exposed to temperatures outside specified limits during storage or distribution.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide