PlainRecalls

Fresenius Medical Care Renal Therapies Group, LLC

20 recalls on record · Latest: Jun 12, 2019

Fresenius Medical Care Renal Therapies Group, LLC Recall Insight

Fresenius Medical Care Renal Therapies Group, LLC appears on 20 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.024% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jun 12, 2019, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 20 entries, severity tagging shows 0 critical, 16 moderate, and 4 lower-severity recalls. Affected-unit counts are disclosed on 20 of 20 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 3 distinct product categories, with issuing agencies dominated by FDA Devices (18), FDA Drug (2). The date window on this page runs from Nov 25, 2015 to Jun 12, 2019.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Low Jun 12, 2019

2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for a…

FDA Devices Moderate Dec 26, 2018

Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E

FDA Devices Low Dec 5, 2018

Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis

FDA Devices Low Dec 5, 2018

Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis

FDA Devices Low Dec 5, 2018

Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis

FDA Devices Moderate Sep 26, 2018

2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: …

FDA Devices Moderate Sep 26, 2018

2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: …

FDA Devices Moderate Jun 13, 2018

NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated t…

FDA Drug Moderate May 30, 2018

0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.

FDA Devices Moderate Apr 11, 2018

2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2…

FDA Drug Moderate Mar 28, 2018

DELFLEX 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), R…

FDA Devices Moderate Jan 25, 2017

Fresenius 2008K@home Series : Hemodialysis System

FDA Devices Moderate Jan 25, 2017

Fresenius 2008K2 Series : Hemodialysis System

FDA Devices Moderate Jan 25, 2017

Fresenius 2008T Series Hemodialysis System

FDA Devices Moderate Jun 29, 2016

Crit 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 c…

FDA Devices Moderate Apr 13, 2016

Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery Sy…

FDA Devices Moderate Feb 3, 2016

Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111

FDA Devices Moderate Nov 25, 2015

Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.

FDA Devices Moderate Nov 25, 2015

Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis.

FDA Devices Moderate Nov 25, 2015

Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds