Fresenius Medical Care Renal Therapies Group, LLC recalls
Every recall we track for Fresenius Medical Care Renal Therapies Group, LLC — 24 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 4 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Fresenius Medical Care Renal Therapies Group, LLC peaked in 2018 (8); 24 since 2017. 17% rated “stop using now”.
All FDA recall records for Fresenius Medical Care Renal Therapies Group, LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 2 | 1 | 2 | 0 | 5 |
| 2018 | 1 | 3 | 3 | 1 | 8 |
| 2019 | 0 | 1 | 0 | 1 | 2 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 1 | 4 | 4 | 0 | 9 |
Most common reasons for Fresenius Medical Care Renal Therapies Group, LLC recalls
What to do if you have a recalled Fresenius Medical Care Renal Therapies Group, LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Fresenius Medical Care Renal Therapies Group, LLC recalls
16 shown- Use cautionMedical device
Fresenius Medical Care Renal Therapies Group, LLC recalls 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Fresenius Medical Care recalls 5008X Standard HD Pre-Flush Standard Blood Tubing Set (Part 03-5110-6) due to heightened risk of blood leaks during dialysis treatment, potentially causing blood loss and hypovolemia.
Fresenius Medical CareAug 10, 2026 - Lower riskMedical device
Fresenius Medical Care Renal Therapies Group, LLC recalls CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
Fresenius Medical Care recalls CombiSet hemodialysis tubing sets with model 03-2522-1. Review instructions to ensure safe use; no immediate action needed but check for proper handling.
Fresenius Medical CareJul 29, 2026 - Lower riskMedical device
Fresenius Medical Care Renal Therapies Group, LLC recalls Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA;
Fresenius Medical Care recalls Citrasate Liquid Acid Concentrate for Bicarbonate Hemodialysis with product numbers 08-2251-CA, 08-3251-CA, and 13-2251-CA due to reported blue-green discoloration in the product.
Fresenius Medical CareJul 14, 2026 - Use cautionMedical device
Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Recall of Fresenius Medical Care 2008T BlueStar Hemodialysis Machines with model numbers 191126 and 191130 due to flow, no water, or temperature-related alarms.
Fresenius Medical CareJun 30, 2026 - Use cautionMedical device
Fresenius Medical Care Renal Therapies Group, LLC recalls Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in
Fresenius Medical Care recalls Liberty Cycler Cassettes used in peritoneal dialysis due to potential leaks from damaged cassettes, risking contamination. Affected cassettes were sold with specific Liberty Cycler sets.
Fresenius Medical CareMay 29, 2019 - UnratedMedical device
Fresenius Medical Care Renal Therapies Group, LLC recalls 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T
Fresenius Medical Care recalls 2008T BlueStar hemodialysis machines with software version 2.72 due to power logic board failure risks.
Fresenius Medical CareApr 3, 2019 - Use cautionMedical device
Fresenius Medical Care Renal Therapies Group, LLC recalls Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Fresenius Medical Care recalls Optiflux F160NR dialyzers with specific lot numbers due to potential external blood leaks. Affected units may require replacement.
Fresenius Medical CareNov 5, 2018 - UnratedMedical device
Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Fresenius recalls Granuflo Dry Acid Concentrate-2K 2.0 Ca 1 Mg 16.5 GAL (Lot 18ETGF005) due to discolored powder containing foreign substances. Affected hemodialysis patients should contact for remedy.
FreseniusOct 9, 2018 - Use cautionMedical device
Fresenius Medical Care Renal Therapies Group, LLC recalls 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part
Fresenius Medical Care recalls 2008T Hemodialysis Systems with BlueStar Premium Upgrade Kit due to risk of disinfectant not fully removed during power failures, potentially contaminating patient dialysate.
Fresenius Medical CareJul 13, 2018 - Lower riskMedical device
Fresenius Medical Care Renal Therapies Group, LLC recalls NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This
Fresenius Medical Care recalls NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis due to mislabeled part numbers. This affects 3.43L bottles with part number 08-3231-1. No action is required as the product is safe but must be correctly labeled.
Fresen:iusMay 2, 2018 - Lower riskMedical device
Fresenius Medical Care Renal Therapies Group, LLC recalls Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and
Fresenius Medical Care is a leading global provider of renal therapies and dialysis solutions. We offer a wide range of products and services for patients with kidney disease, including hemodialysis and peritoneal dialysis solutions.
Fresenius Medical CareJan 24, 2018 - Stop using nowDrug
Fresenius Medical Care Renal Therapies Group, LLC recalls DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2
Fresenius Medical Care recalls DELFLEX Peritoneal Dialysis Solution due to leakage risk. This affects specific 3L and 2L bags with certain lot numbers. Patients should contact the manufacturer for guidance.
Fresenius Medical CareDec 20, 2017 - Use cautionMedical device
Fresenius Medical Care Renal Therapies Group, LLC recalls 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI
Recall of 2008 K2 Hemodialysis Machines with software version 5.40 due to potential high ultrafiltration rates during SLED dialysis programs.
Fresenius Medical CareDec 14, 2017 - Stop using nowDrug
Fresenius Medical Care Renal Therapies Group, LLC recalls 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC
Fresenius Medical Care recalls 1000 mL bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility.
Fresenius Medical CareNov 13, 2017 - Lower riskMedical device
Fresenius Medical Care Renal Therapies Group, LLC recalls 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
Fresenius Medical Care recalls 2008T hemodialysis machines with a software anomaly that may cause incorrect UF rate display. Affected units have specific serial numbers and model codes.
Fresen:ius Medical CareOct 5, 2017 - Lower riskMedical device
Fresenius Medical Care Renal Therapies Group, LLC recalls NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be
Fresenius Medical Care recalls NaturaLyte Liquid Acid Concentrate 2.0 mEq/L (Model 08-2251-0) due to potassium concentration exceeding 2.0 mEq/L in some batches, which may cause health risks during hemodialysis.
Fresenius Medical CareSep 29, 2017
Fresenius Medical Care Renal Therapies Group, LLC recall questions
How many recalls has Fresenius Medical Care Renal Therapies Group, LLC had?
24 recalls from Fresenius Medical Care Renal Therapies Group, LLC are on record with U.S. safety agencies, from 2017–2026 (22 medical device, 2 drug).
What is the most recent Fresenius Medical Care Renal Therapies Group, LLC recall?
Fresenius Medical Care Renal Therapies Group, LLC recalls 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6, dated Aug 10, 2026. Every Fresenius Medical Care Renal Therapies Group, LLC recall is listed on this page, newest first.
Why are Fresenius Medical Care Renal Therapies Group, LLC products recalled?
The most common reasons on record: Complaints of blue-green discoloration in product (3); Discolored powder has confirmed the presence of a foreign substance (3).
What should I do if I have a recalled Fresenius Medical Care Renal Therapies Group, LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Fresenius Medical Care Renal Therapies Group, LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.