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 16 critical, 33 moderate, and 1 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 Sep 28, 2022 to May 13, 2026.

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 Drug Moderate May 13, 2026

DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part …

FDA Drug Moderate May 13, 2026

DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part…

FDA Devices Moderate Dec 24, 2025

5008X CAREsystem +CLiC +CDX;

FDA Devices Moderate Oct 15, 2025

Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM,…

FDA Drug Moderate Jul 2, 2025

0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC…

FDA Devices Moderate Jun 25, 2025

5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b.…

FDA Devices Moderate Jan 15, 2025

Dialyzer Optiflux 160NRe

FDA Devices Moderate Sep 18, 2024

Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines w…

FDA Drug Moderate Jul 24, 2024

DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL exce…

FDA Devices Moderate Jul 17, 2024

RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

FDA Devices Moderate Jul 17, 2024

RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

FDA Devices Moderate Jul 17, 2024

190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

FDA Devices Moderate Jul 17, 2024

190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

FDA Devices Moderate Jul 17, 2024

190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

FDA Devices Moderate Jul 17, 2024

RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

FDA Devices Moderate Jul 17, 2024

191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

FDA Devices Moderate Jul 17, 2024

RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

FDA Devices Moderate Jun 19, 2024

US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Nu…

FDA Devices Moderate May 29, 2024

Blood Pump Rotor, Model Number: F40015481 Rev A

FDA Devices Moderate May 29, 2024

2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

FDA Devices Moderate May 29, 2024

2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

FDA Devices Moderate May 29, 2024

2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

FDA Devices Moderate May 29, 2024

2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A

FDA Devices Moderate May 22, 2024

Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that …

FDA Devices Critical Apr 3, 2024

stay-safe /Luer Lock Adapter 4 in

FDA Devices Critical Apr 3, 2024

stay-safe /Luer Lock Catheter Ext. 18 in

FDA Devices Critical Apr 3, 2024

stay-safe /Luer Catheter Ext. 6 in

FDA Devices Critical Apr 3, 2024

stay-safe /Luer Lock Catheter Ext. 12 in

FDA Devices Critical Apr 3, 2024

stay-safe /Safe Lock Catheter Ext. 12 in

FDA Drug Moderate Jan 10, 2024

DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 0245…

FDA Devices Low Jan 3, 2024

Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111

FDA Devices Moderate Dec 13, 2023

Stay Safe Cap

FDA Devices Critical Oct 18, 2023

2008T HD SYS. W/O CDX BLUESTAR

FDA Devices Critical Oct 18, 2023

2008T Hemodialysis SYS, with CDX

FDA Devices Critical Oct 18, 2023

3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case

FDA Devices Critical Oct 18, 2023

10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

FDA Devices Critical Oct 18, 2023

2008T HD SYS. W/O CDX W/BIBAG BLUESTAR

FDA Devices Critical Oct 18, 2023

10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

FDA Devices Critical Oct 18, 2023

2008T Hemodialysis System w/Bibag

FDA Devices Critical Oct 18, 2023

2008T GEN 2 Bibag without CDX

FDA Devices Critical Oct 18, 2023

2008T HD SYS. CDX W/BIBAG BLUESTAR

FDA Devices Critical Oct 18, 2023

2008T Hemodialysis System without CDX

FDA Devices Critical Oct 18, 2023

2008T HD SYS. CDX BLUESTAR

FDA Drug Moderate Jun 7, 2023

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-…

FDA Devices Moderate Dec 28, 2022

2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 19071…

FDA Drug Moderate Dec 14, 2022

0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, …

FDA Devices Moderate Nov 16, 2022

NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.

FDA Drug Moderate Oct 26, 2022

0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, …

FDA Devices Moderate Sep 28, 2022

AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1…

FDA Devices Moderate Sep 28, 2022

AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 V…

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.