Recall Register

Fresenius Medical Care Renal Therapies Group, LLC: FDA recalls

FDA enforcement reports name Fresenius Medical Care Renal Therapies Group, LLC as the recalling firm in 22 events. The events have 35 product records. The recalls started from 2015 to 2026.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

22 events, newest first.

FDA enforcement events of Fresenius Medical Care Renal Therapies Group, LLC
InitiatedProduct (first record)TypeClassRecordsStatus
10 Aug 20265008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6DeviceClass II4Ongoing
14 Jul 2026GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate HemodialysisDeviceClass II3Ongoing
30 Jun 2026Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.DeviceClass II1Ongoing
29 May 2019Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212 (2) LIBERTY Line Cycler Set with Stay-safe…DeviceClass II1Terminated
3 Apr 20192008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.DeviceClass III1Terminated
5 Nov 2018Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316EDeviceClass II1Terminated
9 Oct 2018Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysisDeviceClass III3Terminated
13 Jul 20182008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.DeviceClass II2Terminated
2 May 2018NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.…DeviceClass II1Terminated
24 Jan 2018Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.DeviceClass II1Terminated
20 Dec 2017DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.DrugClass II1Terminated
14 Dec 20172008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.DeviceClass II1Terminated
13 Nov 20170.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.DrugClass II1Terminated
5 Oct 20172008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.DeviceClass II1Terminated
29 Sep 2017NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.DeviceClass II1Terminated
21 Dec 2016Fresenius 2008T Series Hemodialysis SystemDeviceClass II4Terminated
24 May 2016Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis Machines as follows: Model: 190895 2008T GEN 2…DeviceClass II1Terminated
10 Mar 2016Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine The Fresenius 2008¿ Series Machines are indicated for acute and chronic dialysis…DeviceClass II1Terminated
26 Feb 2016Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic HemodialysisDeviceClass II1Terminated
18 Jan 2016Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate DialysisDeviceClass II1Terminated
15 Dec 2015Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111DeviceClass II1Terminated
23 Oct 2015Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.DeviceClass II3Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Fresenius Medical Care Renal Therapies Group, LLC: events for each product type
TypeEvents
Device20
Drug2
Fresenius Medical Care Renal Therapies Group, LLC: events in each class
ClassEvents
Class II20
Class III2
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
3

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Fresenius Medical Care Renal Therapies Group, LLC, by the year that the recall started. The largest year is 2016, with 5 events.

Official channels

Cite this page

Recall Register. Fresenius Medical Care Renal Therapies Group, LLC: FDA recalls. https://recallregister.com/firm/fresenius-medical-care-renal-therapies-group-llc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
MA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Fresenius Medical Care Renal Therapies Group, LLC have?
Class II: 20 events. Class III: 2 events. The class is for the product of a recall. It is not a class of the firm.
Which product types do the FDA recalls of Fresenius Medical Care Renal Therapies Group, LLC have?
Device: 20 events. Drug: 2 events.
What is the newest FDA recall of Fresenius Medical Care Renal Therapies Group, LLC?
FDA event 99556, which the firm started on 10 Aug 2026. The first product in the record is: 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
How many FDA recalls of Fresenius Medical Care Renal Therapies Group, LLC have the status Ongoing?
3 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.