Fresenius Medical Care Holdings, Inc.

Complete recall history across all FDA and CPSC categories — 161 total recalls

Fresenius Medical Care Holdings, Inc. appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (16)

FDA drug safety enforcement actions by Fresenius Medical Care Holdings, Inc.

Date Product Reason Class
May 27, 2025 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fres... Lack of Assurance of Sterility Class II
Jun 18, 2024 DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% D... This product is being recalled due to the tube weld failure presents itself a... Class II
Dec 28, 2023 DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, pack... Lack of Sterility Assurance Class II
May 23, 2023 Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx onl... Lack of assurance of sterility: The product was potentially exposed to below-... Class II
Nov 22, 2022 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, U... Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection... Class II
Oct 11, 2022 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, U... Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection... Class II
Apr 28, 2021 DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack... Temperature Abuse: Product exposed to temperature outside specified limits. Class III
Apr 28, 2021 DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low C... Temperature Abuse: Product exposed to temperature outside specified limits. Class III
Apr 28, 2021 DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low C... Temperature Abuse: Product exposed to temperature outside specified limits. Class III
Apr 28, 2021 DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low C... Temperature Abuse: Product exposed to temperature outside specified limits. Class III
Apr 28, 2021 DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low ... Temperature Abuse: Product exposed to temperature outside specified limits. Class III
Apr 28, 2021 DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low ... Temperature Abuse: Product exposed to temperature outside specified limits. Class III
Apr 28, 2021 DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low ... Temperature Abuse: Product exposed to temperature outside specified limits. Class III
Apr 28, 2021 Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North Amer... Temperature Abuse: Product exposed to temperature outside specified limits. Class II
Mar 5, 2020 Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: ... CGMP Deviation: Chemical indicators were not positioned properly during steri... Class II
Apr 14, 2014 phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufact... Cross Contamination with Other Products: Potential for contaminant on the cot... Class II

Device Recalls (145)

FDA medical device enforcement actions by Fresenius Medical Care Holdings, Inc.. Showing most recent 50.

Date Product Reason Class
Oct 25, 2025 5008X CAREsystem +CLiC +CDX; Several software anomalies with the potential to impact patient treatment, of... Class II
Aug 29, 2025 Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F16... To provide further information to the user to ensure proper use of the medica... Class II
Apr 29, 2025 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the followin... Potential of blood leak occurring between the lower port of the venous chambe... Class II
Dec 5, 2024 Dialyzer Optiflux 160NRe Potential for internal blood leaks due to cracked polyurethane Class II
Aug 8, 2024 Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) wit... Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM... Class II
Jun 3, 2024 RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Mode... An increased number of complaints were reported on the Blood Pump Rotor (P/N ... Class II
Jun 3, 2024 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, ... An increased number of complaints were reported on the Blood Pump Rotor (P/N ... Class II
Jun 3, 2024 RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare p... An increased number of complaints were reported on the Blood Pump Rotor (P/N ... Class II
Jun 3, 2024 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model N... An increased number of complaints were reported on the Blood Pump Rotor (P/N ... Class II
Jun 3, 2024 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part... An increased number of complaints were reported on the Blood Pump Rotor (P/N ... Class II
Jun 3, 2024 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part,... An increased number of complaints were reported on the Blood Pump Rotor (P/N ... Class II
Jun 3, 2024 RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare ... An increased number of complaints were reported on the Blood Pump Rotor (P/N ... Class II
Jun 3, 2024 RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare p... An increased number of complaints were reported on the Blood Pump Rotor (P/N ... Class II
May 16, 2024 US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be u... Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard d... Class II
Apr 17, 2024 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump ... An increased number of complaints were reported on the Blood Pump Rotor (P/N ... Class II
Apr 17, 2024 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump ... An increased number of complaints were reported on the Blood Pump Rotor (P/N ... Class II
Apr 17, 2024 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump ... An increased number of complaints were reported on the Blood Pump Rotor (P/N ... Class II
Apr 17, 2024 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump ... An increased number of complaints were reported on the Blood Pump Rotor (P/N ... Class II
Apr 17, 2024 Blood Pump Rotor, Model Number: F40015481 Rev A An increased number of complaints were reported on the Blood Pump Rotor (P/N ... Class II
Apr 8, 2024 Novalung sensor box is a component of the Novalung Console (F30000162)-Indica... Issue related to Novalung sensor box, which is a component of the Novalung Co... Class II
Jan 23, 2024 stay-safe /Safe Lock Catheter Ext. 12 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. Class I
Jan 23, 2024 stay-safe /Luer Lock Catheter Ext. 12 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. Class I
Jan 23, 2024 stay-safe /Luer Catheter Ext. 6 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. Class I
Jan 23, 2024 stay-safe /Luer Lock Catheter Ext. 18 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. Class I
Jan 23, 2024 stay-safe /Luer Lock Adapter 4 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. Class I
Oct 24, 2023 Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111 Affected Liberty Select cyclers may display an incorrect time stamp on the tr... Class III
Oct 10, 2023 Stay Safe Cap Updating the labeling to include additional warnings and contraindications fo... Class II
Sep 6, 2023 2008T HD SYS. CDX BLUESTAR Potential PCBA leaching from tubing of hemodialysis machines. Class I
Sep 6, 2023 2008T Hemodialysis System without CDX Potential PCBA leaching from tubing of hemodialysis machines. Class I
Sep 6, 2023 2008T HD SYS. CDX W/BIBAG BLUESTAR Potential PCBA leaching from tubing of hemodialysis machines. Class I
Sep 6, 2023 2008T GEN 2 Bibag without CDX Potential PCBA leaching from tubing of hemodialysis machines. Class I
Sep 6, 2023 2008T Hemodialysis System w/Bibag Potential PCBA leaching from tubing of hemodialysis machines. Class I
Sep 6, 2023 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR Potential PCBA leaching from tubing of hemodialysis machines. Class I
Sep 6, 2023 2008T Hemodialysis SYS, with CDX Potential PCBA leaching from tubing of hemodialysis machines. Class I
Sep 6, 2023 2008T HD SYS. W/O CDX BLUESTAR Potential PCBA leaching from tubing of hemodialysis machines. Class I
Aug 8, 2023 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 b... There is a potential for blood backfill leakage and foreign material. Class I
Aug 8, 2023 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes... There is a potential for blood backfill leakage and foreign material. Class I
Aug 8, 2023 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, ... There is a potential for blood backfill leakage and foreign material. Class I
Oct 4, 2022 NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallo... The "Nominal Chemical Composition" section of the label incorrectly lists 5.6... Class II
Jul 27, 2022 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute a... (1)Software version 2.74 upgrade and (2)hardware related cause that affects o... Class II
Jun 21, 2022 AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended ... Internal ethemet cables are missing one or both ferrite cores therefore the ... Class II
Jun 21, 2022 AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended... Internal ethemet cables are missing one or both ferrite cores therefore the ... Class II
Jun 16, 2022 AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic P... Internal ethernet cable may be misaligned, the cable jacket (insulation) coul... Class II
Jun 16, 2022 AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic P... Internal ethernet cable may be misaligned, the cable jacket (insulation) coul... Class II
Jun 1, 2022 NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3 The product was potentially exposed to below-recommended storage temperatures... Class II
May 31, 2022 NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing e... Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil n... Class II
May 31, 2022 NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing e... Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil n... Class II
May 4, 2022 Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E Dialyzers were distributed after being exposed to cold temperatures which exc... Class II
Dec 7, 2021 Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- ... Error messages 206 (yellow) and 208 (red) technical failure, flow measurement... Class II
Aug 3, 2021 AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - ... AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US ... Class II

View all 145 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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