The Recall Desk

Manufacturer

Fresenius Medical Care Holdings, Inc.

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

What the numbers show

Total
166
Critical
1
Severe
32
Most recent
2026-07-15

Of the 166 recalls from Fresenius Medical Care Holdings, Inc. we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 32 (19%) are Severe.

Which agencies issued them

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.

151–166 of 166

  • HighFDA (Devices)·Z-0184-2014·2013-11-20

    Fresenius Hemodialysis Blood Lines Recalled for Potential Disconnection Risk

    Fresenius Medical Care is recalling 8,528 cases of 2008K@ Home Blood lines due to a risk of disconnection and blood loss if not tightened correctly.

    Product
    2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2014·2013-11-13

    Fresenius Liberty Cycler Recalled for Fluid Leak and Contamination Risk

    Fresenius Medical Care is recalling Liberty Cyclers because fluid leaks may contaminate dialysate, potentially causing peritonitis.

    Product
    Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1693-2013·2013-07-17

    Fresenius Hemodialysis Machine O-Rings Recalled for Incorrect Material

    Fresenius Medical Care is recalling 725 replacement O-rings for hemodialysis machines because they were made of nitrile rubber instead of the required EPDM material.

    Product
    Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1674-2013·2013-07-17

    Fresenius Liberty Cycler Set Recalled for Potential Leakage During Dialysis

    Fresenius Medical Care is recalling 5,480 units of the Liberty Cycler Set due to a risk of cassette leakage during setup or treatment.

    Product
    Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0799-2013·2013-02-20

    Fresenius Liberty Cycler Set Recalled for Leak and Contamination Risk

    Fresenius Medical Care is recalling 5,590 Liberty Cycler Sets due to a small risk of leaks that could contaminate dialysate and cause peritonitis.

    Product
    Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0676-2013·2013-01-23

    Fresenius GranuFlo Dry Acid Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.

    Product
    Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0683-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 670 units distributed nationwide.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL Catalog Number: OFD3201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0679-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling specific lots of GranuFlo Dry Acid Concentrate because the product may show discoloration.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0682-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate due to potential discoloration. The product is used for hemodialysis treatment.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0681-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0684-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 2,711 units distributed nationwide.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0680-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 5 units distributed nationwide.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0678-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 14,240 units distributed nationwide.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0677-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2012·2012-07-04

    Fresenius NaturaLyte Liquid Acid Concentrate Recalled for Alkalosis Risk

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate due to a risk of alkalosis. The product is used for hemodialysis.

    Product
    Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1827-2012·2012-07-04

    Fresenius GranuFlo Acid Concentrate Recalled for Risk of Alkalosis

    Fresenius Medical Care is recalling GranuFlo Acid Concentrate due to a risk of alkalosis in patients undergoing hemodialysis.

    Product
    Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2225-3B, OFD2231-3B, OFD2251-3B, OFD2301-3B, OFD2323-3B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B. For the treatment of acu
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Fresenius Medical Care

German medical supply company

Country
Germany
Founded
1975
Parent company
Fresenius SE & Co. KGaA

Official website

Source: Wikidata (Q650259), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.