Fresenius Medical Care Holdings, Inc.
Complete recall history across all FDA and CPSC categories — 161 total recalls
Recall Summary
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 |
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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