Fresenius Medical Care Renal Therapies Group, LLC
Complete recall history across all FDA and CPSC categories — 27 total recalls
Recall Summary
Fresenius Medical Care Renal Therapies Group, LLC 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 (2)
FDA drug safety enforcement actions by Fresenius Medical Care Renal Therapies Group, LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 20, 2017 | DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged... | Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solut... | Class II |
| Nov 13, 2017 | 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Car... | Lack of Assurance of Sterility | Class II |
Device Recalls (25)
FDA medical device enforcement actions by Fresenius Medical Care Renal Therapies Group, LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| May 29, 2019 | Liberty Cycler Cassettes (a disposable cassette that is intended to be used t... | Additional Instructions: step-by step handling and inserting the cassette int... | Class II |
| Apr 3, 2019 | 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 1... | Power Logic Board Fail Message on the 2008T BlueStar Machine with software ve... | Class III |
| Nov 5, 2018 | Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 05... | Potential for external blood leaks from the dialyzer header | Class II |
| Oct 9, 2018 | Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog ... | Discolored powder has confirmed the presence of a foreign substance | Class III |
| Oct 9, 2018 | Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Num... | Discolored powder has confirmed the presence of a foreign substance | Class III |
| Oct 9, 2018 | Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Num... | Discolored powder has confirmed the presence of a foreign substance | Class III |
| Jul 13, 2018 | 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 20... | In the hemodialysis machine during the cleaning/disinfection program, when th... | Class II |
| Jul 13, 2018 | 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2... | In the hemodialysis machine during the cleaning/disinfection program, when th... | Class II |
| May 2, 2018 | NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Pa... | The bottles are mislabeled with an incorrect part number. | Class II |
| Jan 24, 2018 | Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usa... | The recalling firm identified a software issue related to the Patient Line Ch... | Class II |
| Dec 14, 2017 | 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodial... | When the recirculation ultrafiltration (UF) Goal is set to a value greater th... | Class II |
| Oct 5, 2017 | 2008T, Hemodialysis Delivery System Product Indicated for acute and chroni... | While reviewing documentation for the next software release of the 2008T, an ... | Class II |
| Sep 29, 2017 | NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter... | The label specifies the potassium concentration is 2.0 mEq/L. Some of the pro... | Class II |
| Dec 21, 2016 | Fresenius 2008K Series : Hemodialysis System | When the UF Rate, Goal or Time is adjusted using the up and down arrow ke... | Class II |
| Dec 21, 2016 | Fresenius 2008T Series Hemodialysis System | When the UF Rate, Goal or Time is adjusted using the up and down arrow ke... | Class II |
| Dec 21, 2016 | Fresenius 2008K2 Series : Hemodialysis System | When the UF Rate, Goal or Time is adjusted using the up and down arrow ke... | Class II |
| Dec 21, 2016 | Fresenius 2008K@home Series : Hemodialysis System | When the UF Rate, Goal or Time is adjusted using the up and down arrow ke... | Class II |
| May 24, 2016 | Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-... | Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T ... | Class II |
| Mar 10, 2016 | Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K an... | Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Bl... | Class II |
| Feb 26, 2016 | Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute ... | Dialyzer header leak due to possible improper torque | Class II |
| Jan 18, 2016 | Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 In... | On the label calcium (Ca) listed in the right upper corner of the label (red... | Class II |
| Dec 15, 2015 | Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR18... | The door latch may not fully close and the door may open unexpectedly. The d... | Class II |
| Oct 23, 2015 | Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use i... | Dissolution units and replacement motors units do not provide full thermal pr... | Class II |
| Oct 23, 2015 | Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075... | Dissolution units and replacement motors units do not provide full thermal pr... | Class II |
| Oct 23, 2015 | Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the... | Dissolution units and replacement motors units do not provide full thermal pr... | 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.
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