Fresenius Medical Care Holdings, Inc.
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.
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failu…
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBpl…
NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failu…
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary suppor…
Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysat…
(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…
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 …
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…
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…
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
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…
The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a sta…
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…
Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-…
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…
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 …
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC…
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…
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Fresenius Medical Ca…
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-…
AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic sub…
Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarb…
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarb…
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarb…
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarb…
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicar…
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
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Data Sources
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.