PlainRecalls

Fresenius Medical Care Holdings, Inc.

Compiled from official public sources by the editorial team.

163 recalls on record · Latest: May 13, 2026

Fresenius Medical Care Holdings, Inc. Recall Insight

Fresenius Medical Care Holdings, Inc. appears on 163 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.160% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated May 13, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 43 moderate, and 7 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 2 distinct product categories, with issuing agencies dominated by FDA Devices (42), FDA Drug (8). The date window on this page runs from Jan 20, 2021 to Aug 3, 2022.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Aug 3, 2022

AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US

FDA Devices Moderate Aug 3, 2022

AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

FDA Devices Moderate Jul 20, 2022

NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failu…

FDA Devices Moderate Jul 20, 2022

AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBpl…

FDA Devices Moderate Jul 20, 2022

NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failu…

FDA Devices Moderate Jul 13, 2022

NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3

FDA Devices Moderate Jul 6, 2022

Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E

FDA Devices Moderate Feb 16, 2022

Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary suppor…

FDA Devices Moderate Jul 28, 2021

Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysat…

FDA Devices Moderate Jul 28, 2021

(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage…

FDA Devices Moderate Jul 28, 2021

The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain …

FDA Devices Moderate Jul 28, 2021

Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3…

FDA Devices Moderate Jul 28, 2021

The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector t…

FDA Devices Moderate Jul 28, 2021

026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting

FDA Devices Moderate Jul 28, 2021

NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-s…

FDA Devices Moderate Jul 28, 2021

The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a sta…

FDA Devices Moderate Jul 28, 2021

050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivalent to that for the Freseniu…

FDA Drug Moderate Jun 16, 2021

Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10

FDA Drug Low Jun 16, 2021

DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-…

FDA Drug Low Jun 16, 2021

DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx onl…

FDA Drug Low Jun 16, 2021

DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL …

FDA Drug Low Jun 16, 2021

DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC…

FDA Drug Low Jun 16, 2021

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL ba…

FDA Drug Low Jun 16, 2021

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Fresenius Medical Ca…

FDA Drug Low Jun 16, 2021

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-…

FDA Devices Moderate May 19, 2021

AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic sub…

FDA Devices Moderate Feb 10, 2021

Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9

FDA Devices Moderate Jan 20, 2021

Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

FDA Devices Moderate Jan 20, 2021

Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarb…

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarb…

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

FDA Devices Moderate Jan 20, 2021

Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarb…

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

FDA Devices Moderate Jan 20, 2021

Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

FDA Devices Moderate Jan 20, 2021

Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

FDA Devices Moderate Jan 20, 2021

Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarb…

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

FDA Devices Moderate Jan 20, 2021

Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

FDA Devices Moderate Jan 20, 2021

Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicar…

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

FDA Devices Moderate Jan 20, 2021

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

FDA Devices Moderate Jan 20, 2021

Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Fresenius Medical Care Holdings, Inc. with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.