The Recall Desk

Manufacturer

Nipro Renal Soultions USA, Corporation

6 recalls in our database name Nipro Renal Soultions USA, Corporation as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
4
Most recent
2026-09-16

Of the 6 recalls from Nipro Renal Soultions USA, Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (67%) are Severe.

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.

1–6 of 6

  • SevereFDA (Devices)·Z-3133-2026·2026-09-16

    MedicaLyte Liquid Bicarbonate Concentrate Recalled for High Endotoxin Levels

    Nipro Renal Solutions is recalling MedicaLyte Liquid Bicarbonate Concentrate due to high endotoxin levels. The product is used in hemodialysis.

    Product
    MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3136-2026·2026-09-16

    Nipro Citric Complete Liquid Citric Acid Concentrate Recalled for High Endotoxin Levels

    Nipro Renal Solutions is recalling Citric Complete Liquid Citric Acid Concentrate due to high endotoxin levels. The product was distributed in the US and internationally.

    Product
    Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3134-2026·2026-09-16

    Nipro MedicaLyte Bicarbonate Powder Recalled for High Endotoxin Levels

    Nipro Renal Solutions is recalling MedicaLyte Bicarbonate Powder due to high endotoxin levels. The recall affects 2,327 cases distributed in the US, Guatemala, and Panama.

    Product
    MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1730-2025·2025-05-21

    MedicaLyte Liquid Bicarbonate Concentrate Recalled for Foreign Matter

    Nipro Renal Solutions USA is recalling MedicaLyte Liquid Bicarbonate Concentrate (models BC+201 and BC+100) due to the potential presence of visible foreign matter in the product.

    Product
    MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0820-2025·2025-01-15

    Citric acid dialysis concentrate recalled for incorrect case labeling

    Nipro Renal Solutions USA is recalling Citric Complete dry citric acid concentrate due to mislabeled outer cases that show incorrect potassium and calcium content values.

    Product
    Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
    Category
    Medical Device
    Distribution
    10 states